ReagentsInfectious diseases

Infectious immunology - rapid tests & point of care

EMDN code W010509

185 manufacturers, 3,457 models including 3,408 on the market, 24 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 185

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Adenovirus pneumoniae and RSV Combo Test Cassette FI-AR-50298/79 Adenovirus pneumoniae and RSV Combo Test Cassette(Swab)98/79 Adenovirus pneumoniae/RSV/Influenza A+B ComboTest Cassette98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Cassette98/79 378 others Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Control98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Control98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 AUTOTESTE COVID-19 Ag(SALIVA)98/79 Bacterial Diarrhea (Shigella/Salmonella/C.diff) Control98/79 berkeleyhealth Easy Check Strep A rapid test (Professional)98/79 Berkeleyhealth Easy Check Strep A rapid test cassette98/79 Bordetella pertussis Antigen Control SCBP-S98/79 Brucella Abortus Control98/79 CARBA-5 Rapid Test98/79 Casete de Prueba Rápida de Legionella pneumophila98/79 Cassette Test Rapide Strep A98/79 Chagas Control SCCHA-D98/79 Chikungumya lgG&lgM/Dengue lgG&lgM/Dengue NS1 Combo Rapid Test98/79 Chikungunya IgG/IgM Antibody Control SCCHI-D-L98/79 Chikungunya/Zika Combo Rapid Test ICZ-42598/79 Chlamydia Rapid Test Cassette ICH-50298/79 Chlamydia Rapid Test ICH-50298/79 Chlamydia Rapid Test ICH-N502FH-013 refs Clostridium difficile GDH + Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICD-635B98/79 Clostridium difficile GDH + Toxin A + Toxin B Control SCCD-D-L98/79 Clostridium difficile GDH Control SCCDG-D-L98/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette ICD-63598/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette ICD-635B98/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette with LF READER PLUS98/79 Clostridium difficile GDH+Toxin A/B Test Cassette FI-CD-60298/79 Clostridium difficile GDH/Toxin A/Toxin B Test Cassette FI-CD-602B98/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-62598/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-625B98/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-R625B98/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette ICDT-R625B98/79 Clostridium difficile Toxin A/ toxin B Combo Test Cassette FI-CDT-62598/79 Clostridium difficileToxin A+Toxin B Combo Rapid Test Cassette2 refs98/79 Combo Prueba Rápida Clostridium difficile GDH+Toxina A+Toxina B en Casete98/79 COVID-19 and Influenza A+B Antigen Combo Control98/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test98/79 COVID-19 Antigen Rapid Test6 refs98/79 COVID-19 Antigen Rapid Test (Oral Fluid)98/79 COVID-19 Antigen Rapid Test Cassette(Oral Fluid)98/79 COVID-19 Antigen Rapid Test(Nasopharyngeal Swab)98/79 COVID-19 Antigen Rapid Test-ITA98/79 COVID-19 Antigen Test Cassette(Swab)98/79 COVID-19 IgG Control98/79 COVID-19 IgG/IgM Rapid Test2 refs98/79 Cryptococcus Antigen Control SCCRG-D-L98/79 Cryptosporidium Antigen Control SCCRY-D-L98/79 Cryptosporidium Control SCCRY-L98/79 Dengue IgG/IgM Rapid Test Cassette IDEN-40298/79 Dengue IgG/IgM Rapid Test Cassette with LF READER PLUS98/79 Dengue Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IDEC-42598/79 Dengue Combo Rapid Test Cassette IDEC-R42598/79 Dengue Combo Rapid Test IDEC-N425-103 refs Dengue IgG&IgM/Zika IgG&IgM/Chikungunya IgG/Chikungunya IgM Combo Rapid Test Cassette (Serum/Plasma/Whole blood) 25T/kit98/79 Dengue IgG&IgM/Zika IgG&IgM/Chikungunya IgG/Chikungunya IgM Combo Rapid Test Cassette (Serum/Plasma/Whole blood) IDZC-44598/79 Dengue IgG/IgM And NS1 Combo Rapid Test Cassette98/79 Dengue IgG/IgM Control SCDEGM-L98/79 Dengue IgG/IgM Rapid Test Cassette IDEN-R40298/79 Dengue IgG/IgM Rapid Test IDEN-N402-103 refs Dengue NS1 and Zika NS1 Combo Rapid Test98/79 Dengue NS1 Rapid Test3 refs Dengue NS1 Rapid Test Cassette2 refs98/79 Dengue NS1 Rapid Test Cassette with LF READER PLUS98/79 Dengue NS1 Test Cassette (Whole Blood/Serum/Plasma)98/79 Dengue Ns1/Dengue lgG&lgM/Chikungunya lgG&lgM/West Nile Virus lgG&lgM Combo Rapid Test98/79 Dengue Ns1/Dengue lgG&lgM/Chikungunya lgG&lgM/zika lgG&lgM Combo Rapid Test98/79 Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) IDEN-40298/79 EBV VCA and EBNA IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IECNG-42598/79 Entamoeba/Giardia/Crypto Control2 refs98/79 Family Health Self Test Helicobacter Pylori IHP-N602H-013 refs FIA Control-(Clostridium difficile GDH)98/79 FIA Control-(Clostridium difficile GDH+Toxin A/B)98/79 FIA Control-(Rotavirus and Adenovirus Combo)98/79 FIA Control-COVID-19 Ag/Influenza A+B98/79 FIA Control-COVID-19 Antigen98/79 FIA Control-Dengue IgG/IgM98/79 FIA Control-Dengue NS198/79 FIA Control-FLU A+B98/79 FIA Control-H. pylori Antigen98/79 FIA Control-Legionella pneumophila98/79 FIA Control-RSV98/79 FIA Control-Strep A98/79 FIA Control-Streptococcus pneumoniae98/79 FIA Control-Syphilis98/79 FLU A+B Test Cassette98/79 Gesunder Magen2 refs98/79 Giardia Lamblia Control SCGL-D-L98/79 H. pylori Antibody Rapid Test Cassette (Serum /Plasma) IHP-30298/79 H. pylori Antibody Rapid Test Cassette IHP-40298/79 H. pylori Antibody Rapid Test Cassette IHP-R40298/79 H. pylori Antibody Rapid Test IHP-N4023 refs H. pylori Antigen Rapid Test (Feces) IHP-60798/79 H. pylori Antigen Rapid Test Cassette (Feces) IHP-60298/79 H. pylori Antigen Rapid Test Cassette IHP-602H98/79 H. pylori Antigen Rapid Test Cassette(Feces) IHP-602H98/79 H. pylori Antigen Rapid Test IHP-602H98/79 H. pylori Antigen Rapid Test IHP-N601-253 refs H.pylori Antibody Rapid Test IHP-40298/79 H.pylori Antibody Rapid Test IHP-N402B98/79 H.pylori Antibody Rapid Test IHP-N402J98/79 H.pylori Antigen Rapid Test Cassette IHP-60298/79 H.pylori Antigen Rapid Test IHP-60198/79 H.pylori Antigen Rapid Test IHP-60298/79 H1N1 Antigen Rapid Test Cassette98/79 HAV IgG/IgM&Syphilis Combo Rapid Test IHAS-43598/79 HAV IgM&Syphilis Combo Rapid Test IHAS-42598/79 HBsAg Rapid Test Cassette (Whole Blood/Serum/Plasma) IHBSG-40298/79 HBsAg Rapid Test Cassette IHBSG-40298/79 HCV Rapid Test Cassette IHC-40298/79 HCV Rapid Test IHC-40298/79 Hexagon HbsAg98/79 Hexagon HIV98/79 HIV 1.2 Rapid Test Cassette2 refs98/79 HIV 1.2 Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HIV 1.2.O Rapid Test Cassette(WB/S/P)98/79 HPIV Control98/79 HPV Antigen Control SCHPV-S98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette98/79 Human Metapneumovirus Antigen Control SCHMPV-D-L98/79 Influenza A Rapid Test Cassette IFLA-50298/79 Influenza A Rapid Test Cassette IFLA-R50298/79 Influenza A Rapid Test Cassette with LF READER PLUS98/79 Influenza A Rapid Test Dipstick98/79 Influenza A+B Rapid Test3 refs Influenza A+B Rapid Test Cassette IIN-50298/79 Influenza A+B Rapid Test Cassette IIN-R50298/79 Influenza A+B Rapid Test Cassette(Swab / Nasal Aspirate)98/79 Influenza A+B Rapid Test Dipstick98/79 Influenza A+B Rapid Test IIN-R50298/79 Influenza A/B + H5N1 Antigen Combo Rapid Test98/79 Influenza A/B +H1N1 Combo Rapid Test Cassette with LF READER PLUS98/79 Influenza A/B+H1N1 Combo Rapid Test Cassette2 refs98/79 Influenza A/B+H1N1 Control98/79 Influenza A/B+H1N1+H5N1 Antigen Combo Rapid Test98/79 Legionella pneumophila Control3 refs98/79 Legionella pneumophila Rapid Test3 refs Legionella pneumophila Rapid Test Cassette98/79 Legionella pneumophila Rapid Test Cassette (Urine)98/79 Legionella pneumophila Test Cassette (Urine)98/79 Leptospira IgG/IgM Antibody Control SCLEP-L98/79 Magsår H. Pylori98/79 Malaria Antibody Rapid Test IMAB-40298/79 Malaria P.f. /P.v. Rapid Test Cassette (Whole Blood) IMPV-40298/79 Malaria P.f. /P.v. Rapid Test Cassette IMPV-R40298/79 Malaria P.f. /P.v. Rapid Test IMPV-N402-203 refs Malaria P.f. /Pan Rapid Test Cassette (Whole Blood) IMPN-40298/79 Malaria P.f. /Pan Rapid Test IMPN-N402-203 refs Malaria P.f. Rapid Test Cassette98/79 Malaria P.f. Rapid Test Cassette (Whole Blood) IMA-40298/79 Malaria P.f./P.v. /Pan Rapid Test Cassette IMPVF-40298/79 Malaria P.f./P.v. Rapid Test Cassette IMPV-40298/79 Malaria P.f./P.v. Rapid Test Dipstick98/79 Malaria P.f./P.v. Rapid Test IMPV-40198/79 Malaria P.f./P.v./Pan Rapid Test Cassette IMPVF-R40298/79 Malaria P.f./P.v./Pan Rapid Test Malaria Test Cassette IMPVF-40298/79 Malaria P.f./P.v./Pan Rapid Test Malaria Test IMPVF-40298/79 Malaria P.f./Pan Rapid Test Cassette IMPN-R40298/79 Malaria P.f./Pan Rapid Test Dipstick98/79 Malaria P.f./Pan Rapid Test IMPN-40198/79 Mivolis H. pylori Antigen Rapid Test Cassette98/79 Mivolis Schnelltest Gesunder Magen2 refs98/79 Monkeypox Virus Antibody Control SCMXB-L98/79 Monkeypox Virus Antibody Rapid Test IMXB-40298/79 Monkeypox Virus Antibody Rapid Test IMXB-R40298/79 Monkeypox Virus Antibody Test Cassette FI-MXB-40298/79 Monkeypox Virus Antigen Control SCMXG-D-L98/79 Monkeypox Virus Antigen Rapid Test IMXG-40298/79 Monkeypox Virus Antigen Rapid Test IMXG-R40298/79 Monkeypox Virus Antigen Test Cassette FI-MXG-40298/79 MONO Rapid Test Cassette IMO-40298/79 MONO Rapid Test Cassette IMO-R40298/79 MONO Rapid Test IMO-40298/79 MONO Rapid Test IMO-N402-253 refs Multiplex Respiratory Antigen Control SCRTC-S98/79 Multiplex Respiratory Antigen Rapid Test (Flu B/Flu A/HPIV 1/3/HPIV 2/HMPV/Adeno/MP/RSV/COVID-19)98/79 Multiplex Respiratory Antigen Rapid Test IRT9-55598/79 Multiplex Respiratory Antigen Rapid Test IRT9-R55598/79 Multiplex Respiratory Antigen Rapid Test IRTC-510598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5105(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5105(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5105(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-511598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5115(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5115(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-512598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5125(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5125(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-513598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5135(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5135(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-514598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5145(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5145(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-515598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5155(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5155(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5165(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5165(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5175(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5175(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5185(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5185(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5195(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5195(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5205(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5205(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5215(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-52598/79 Multiplex Respiratory Antigen Rapid Test IRTC-525(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-525(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-525(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-53598/79 Multiplex Respiratory Antigen Rapid Test IRTC-535(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-535(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-535(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-54598/79 Multiplex Respiratory Antigen Rapid Test IRTC-545(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-545(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-545(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-55598/79 Multiplex Respiratory Antigen Rapid Test IRTC-555(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-555(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-555(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-56598/79 Multiplex Respiratory Antigen Rapid Test IRTC-565(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-565(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-57598/79 Multiplex Respiratory Antigen Rapid Test IRTC-575(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-575(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-58598/79 Multiplex Respiratory Antigen Rapid Test IRTC-585(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-585(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-585(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-59598/79 Multiplex Respiratory Antigen Rapid Test IRTC-595(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-595(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5X598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5X5(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5X5(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5X5(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-R510598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R511598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R512598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R513598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R514598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R515598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R52598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R53598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R54598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R55598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R56598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R57598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R58598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R59598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R5X598/79 Mycoplasma pneumoniae IgG/IgM Control SCMPGM-L98/79 Mycoplasma pneumoniae IgM Control SCMPM-L98/79 Norovirus+Rotavirus+Adenovirus+Astrovirus Combo Rapid Test IMVD-R64598/79 Norovirus+Rotavirus/Adenovirus+Astrovirus+Enterovirus Combo Rapid Test IMVD-65598/79 Norovirus/Astorvirus/Enterovirus Combo Control98/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test INRA-63798/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test INRA-RT63598/79 Norovirus/Rotavirus/Adenovirus Combo Test Cassette FI-NRA-63598/79 Prueba Rápida de antígeno de H. Pylori en casete98/79 Prueba Rápida de HBsAg en Casete98/79 Prueba Rápida de Mononucleosis en Casete98/79 Prueba Rápida de S. pneumoniae Antígeno en Casete98/79 Respiratory Infectious Diseases Rapid Test IRT-510798/79 Respiratory Infectious Diseases Rapid Test IRT-511798/79 Respiratory Infectious Diseases Rapid Test IRT-512798/79 Respiratory Infectious Diseases Rapid Test IRT-513798/79 Respiratory Infectious Diseases Rapid Test IRT-514798/79 Respiratory Infectious Diseases Rapid Test IRT-515798/79 Respiratory Infectious Diseases Rapid Test IRT-52798/79 Respiratory Infectious Diseases Rapid Test IRT-53798/79 Respiratory Infectious Diseases Rapid Test IRT-54798/79 Respiratory Infectious Diseases Rapid Test IRT-55798/79 Respiratory Infectious Diseases Rapid Test IRT-56798/79 Respiratory Infectious Diseases Rapid Test IRT-57798/79 Respiratory Infectious Diseases Rapid Test IRT-58798/79 Respiratory Infectious Diseases Rapid Test IRT-59798/79 Respiratory Infectious Diseases Rapid Test IRT-5X798/79 Rhinovirus Control SCRHV-S98/79 Rotavirus Group A and Norovirus GI/GII RT-qPCR Kit2 refs98/79 Rotavirus/Adenovirus+Astrovirus Combo Rapid Test IRAA-62598/79 RPR Reagents5 refs98/79 RSV &Influenza A+B Combo Rapid Test Cassette IRIC-R52598/79 RSV and SARS-CoV-2 Antigen Combo Rapid Test98/79 RSV Rapid Test Cassette IRS-50298/79 RSV RapidTest Cassette98/79 RSV Test Cassette (Nasopharyngeal Swab/Nasal Aspirate)98/79 RSV Test Cassette FI-RSV-50298/79 RSV Test Cassette(Swab)98/79 RSV&Influenza A+B Combo Rapid Test Cassette IRIC-52598/79 RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 S. pneumoniae and L. pneumophila Control98/79 S. pneumoniae Antigen Rapid Test Cassette ISP-10298/79 S. pneumoniae Antigen Rapid Test Cassette ISP-R10298/79 S. pneumoniae Antigen Rapid Test ISP-N102-103 refs S. pneumoniae/ L. pneumophila Control98/79 S.pneumoniae Antigen Rapid Test Cassette (Urine) ISP-10298/79 Salmonella paratyphi Antigen Control98/79 Salmonella typhi and paratyphi Antigen Control98/79 Salmonella typhi Antigen Control98/79 SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva)2 refs98/79 SARS-CoV-2 a chřipka A+B Antigen Combo Rychly test (Vytěr z nosu)98/79 SARS-COV-2 and Influenza A+B Antigen Combo Rapid Test3 refs98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab)98/79 SARS-CoV-2 Antigen Control2 refs98/79 SARS-CoV-2 Antigen Rapid Test2 refs98/79 SARS-CoV-2 Antigen Rapid Test (Swab)98/79 SARS-CoV-2 Neutralization Antibody Rapid Test98/79 SARS-CoV-2 S-RBD Antibody Rapid Test98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test2 refs98/79 SARS-COV-2(COVID-19) Antigen Rapid Test2 refs98/79 SARS-CoV-2-Antigen-Schnelltest (Nasenabstrich)98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Control98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/ Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/ Adenovirus/ M.pneumoniae Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/ Adenovirus/M. pneumoniae Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 Schnelltest Gesunder Magen98/79 SCREEN® Strep A Test3 refs Scrub Typhus IgG/IgM Control98/79 Shigella Flexneri Control98/79 Shigella Sonnei Control98/79 Strep A Rapid Test Cassette (Control Line in Blue)(Throat Swab)98/79 Strep A Rapid Test Cassette (Control Line in Red) IST-50298/79 Strep A Rapid Test Cassette (Throat Swab)2 refs98/79 Strep A Rapid Test Cassette IST-50298/79 Strep A Rapid Test Cassette IST-N50298/79 Strep A Rapid Test Cassette IST-R50298/79 Strep A Rapid Test Cassette ISTB-50298/79 Strep A Rapid Test Cassette ISTB-R50298/79 Strep A Rapid Test Dipstick98/79 Strep A Rapid Test Dipstick (Throat Swab)98/79 Strep A Rapid Test IST-50198/79 Strep A Rapid Test IST-N5013 refs Strep A Rapid Test ISTB-N501-253 refs Strep A Test Cassette FI-STA-50298/79 Strep A Test Cassette(Swab)98/79 Strep B Rapid Test Cassette (Swab) ISB-50298/79 Strep B Rapid Test Cassette ISB-50298/79 Strep B Rapid Test Cassette ISB-R50298/79 Strep B Rapid Test Dipstick98/79 Streptococcus pneumoniae Antigen Rapid Test Cassette2 refs98/79 Streptococcus pneumoniae Antigen Rapid Test Cassette with LF READER ATR-001,10 T/kit98/79 Streptococcus Pneumoniae Antigen Test Cassette98/79 Streptococcus pneumoniae Control2 refs98/79 Streptococcus pneumoniae Test Cassette98/79 Streptococcus pneumoniae Test Cassette (Urine)98/79 SYP Test Cassette98/79 Syphilis Rapid Test (Oral Fluid) ISY-80398/79 Syphilis Rapid Test Cassette ISY-30298/79 Syphilis Rapid Test Cassette ISY-40298/79 Syphilis Rapid Test Cassette ISY-R30298/79 Syphilis Rapid Test Dipstick2 refs98/79 Syphilis Rapid Test Dipstick (Whole Blood /Serum/Plasma)98/79 Syphilis Rapid Test ISY-40298/79 Syphilis Rapid Test ISY-80398/79 Syphilis Rapid Test ISY-N4013 refs Syphilis Test Kit (CLIA)98/79 Szybki test kasetkowy do wykrywania Helicobacter pylori w kale98/79 Test Rapide de l’antigène SARS-CoV-2 (écouvillon nasal)98/79 Teste rápido em cassete de HIV 1.2(Sangue Total/Soro/Plasma)98/79 Tetanus Control SCTET-D-L98/79 TPHA Reagents3 refs98/79 Trichomonas Vaginalis Control SCTV-D-L98/79 Trichomonas vaginalis/Gardnerella vaginalis/Candida albicans Combo Rapid Test98/79 TropiDetect Triple Test98/79 Vibrio cholerae O1/O139 Control98/79 ZIKA IgG Control SCZIBG-D98/79 Zika IgG/IgM Control SCZIB-L98/79 ZuhauseTEST Gesunder Magen2 refs98/79	B, C IVDR, 98/79	info@alltests.com.cn EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	United States	Adenovirus / RSV / Influenza A+B Combo Rapid Test Cassette IARI-R53598/79 Adenovirus and RSV Combo Rapid Test Cassette (Nasopharyngeal Swab) IARC-R52598/79 Adenovirus Control SCADE-D-L98/79 Adenovirus pneumoniae/RSV/Influenza A+B Combo Test Cassette acrARF535F98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 208 others Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Cassette98/79 Adenovirus+RSV Control SCARC-S98/79 Adenovirus/Rotavirus Control SCRAC-D-L98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Control98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Control98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Control98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Adenovirus/RSV/Influenza A+B Control SCARI-S98/79 Astrovirus Control SCAS-D-L98/79 Bordetella pertussis Antigen Control98/79 Brucella Abortus Control2 refs98/79 Campylobacter Control SCCAM-D-L98/79 Candida Albicans Control SCCA-D-L98/79 Chagas Control SCCHA-D98/79 Chikungunya and Dengue Combo Rapid Test acrCKDE43598/79 Chikungunya control98/79 Chikungunya IgG/IgM Antibody Control SCCHI-D-L98/79 Chikungunya IgG/IgM Control98/79 Chikungunya/Zika Combo Rapid Test ICZ-ACO42598/79 Clostridium difficile GDH + Toxin A + Toxin B Control SCCD-D-L98/79 Clostridium difficile GDH Control SCCDG-D-L98/79 Clostridium difficile GDH Rapid Test Cassette ICDG-R60298/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICD-63598/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test ICD-ACO63798/79 Clostridium difficile GDH+Toxin A+Toxin B Combo Rapid Test Cassette ICD-R635B98/79 Clostridium difficile GDH+Toxin A/B Test Cassette ACO-CD-60298/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette (Feces) ICDT-R625B98/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICDT-62598/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICDT-625B98/79 Clostridium difficile Toxin A +Toxin B Control SCCDT-D-L98/79 Clostridium difficile Toxin A/ toxin B Combo Test Cassette (Feces) ACO-CDT-62598/79 COVID-19 and Influenza A+B Antigen Combo Control98/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test2 refs98/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 COVID-19 Antigen Control2 refs98/79 COVID-19 Antigen Rapid Test (Oral Fluid)98/79 COVID-19 IgG Control98/79 COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 Nab Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 S-RBD Ab Rapid Test (Whole Blood/Serum/Plasma)98/79 Cryptococcus Antigen Control98/79 Cryptosporidium Antigen Control SCCRY-D-L98/79 Cryptosporidium Control SCCRY-L98/79 Dengue IgG/IgM Control SCDEGM-L98/79 Dengue NS1 and Zika NS1 Combo Rapid Test98/79 Dengue NS1 Control3 refs98/79 Dengue NS1 Rapid Test Cassette (Whole Blood/ Serum/ Plasma)2 refs98/79 Dengue/Chikungunya/West Nile Virus Combo Rapid Test acrDCW44598/79 Dengue/Chikungunya/Zika Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IDCZ-R43598/79 Dengue/Chikungunya/Zika Combo Rapid Test Cassette IDCZ-ACO43598/79 Dengue/Zika/Chikungunya Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IDZC-R44598/79 Dengue/Zika/Chikungunya Combo Rapid Test Cassette IDZC-ACO44598/79 EBNA IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) IENG-R40298/79 EBV VCA and EBNA IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IECNG-R42598/79 EBV VCA IgA Rapid Test Cassette (Whole Blood/ Serum/ Plasma) IECA-ACO40298/79 EBV VCA IgG Rapid Test (Whole Blood/Serum/Plasma) IECG-R40298/79 Entamoeba Histolytica Control SCEH-D-L98/79 Entamoeba/Giardia/Crypto Control2 refs98/79 FIA Control50 refs98/79 FIA Control CA125 Control98/79 FIA Control CA19-9 Control98/79 FIA Control SARS-CoV-2/Influenza A+B/RSV Antigen Control98/79 FIA Control Vibrio cholerae O1/O139 Control98/79 Giardia Lamblia Control SCGL-D-L98/79 H. pylori Antigen Control SCHPG-D-L98/79 H.pylori Ag Control SCHPG-S98/79 H1N1 Antigen Rapid Test Cassette (Swab)98/79 HAV IgG/IgM&Syphilis Combo Rapid Test IHAS-ACO43598/79 HAV IgM&Syphilis Combo Rapid Test IHAS-ACO42598/79 HPIV Control98/79 HPV Control SCHPV-S98/79 HSV 1/2 IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Human Metapneumovirus Antigen Control SCHMPV-D-L98/79 Influenza A Control SCFLA-S98/79 Influenza A Rapid Test Cassette (Swab/Nasal Aspirate)2 refs98/79 Influenza A Rapid Test Dipstick (Swab/Nasal Aspirate)98/79 Influenza A+B Rapid Test Cassette FLU2E98/79 Influenza A+B Rapid Test Cassette(Swab/Nasal Aspirate)98/79 Influenza A+B Rapid Test Dipstick (Swab/Nasal Aspirate)98/79 Influenza A+BRapid Test Cassette98/79 Influenza A/B +H1N1 Combo Rapid Test Cassette (Swab)98/79 Influenza A/B+H1N1 Combo Control98/79 Legionella pneumophila Control2 refs98/79 Legionella Pneumophila Rapid Test Cassette (Urine)98/79 Leptospira IgG/IgM Antibody Control SCLEP-L98/79 Malaria Antibody Rapid Test IMAB-ACO40298/79 Malaria P.f. /P.v. Rapid Test Cassette (Whole Blood) IMPV-R40298/79 Malaria P.f. Control SCMPF-D98/79 Malaria P.f. Rapid Test Cassette (Whole Blood) IMA-R40298/79 Malaria P.f./P.v. /Pan Rapid Test Cassette MFVP2D98/79 Malaria P.f./P.v. Control SCMPV-D98/79 Malaria P.f./P.v./Pan Control SCMPVF-D98/79 Malaria P.f./P.v./Pan Rapid Test Cassette acrMPVF402R98/79 Malaria P.f./P.v./Pan Rapid Test Cassette IMPVF-40298/79 Malaria P.f./Pan Rapid Test Cassette (Whole Blood) IMPN-R40298/79 Monkeypox Virus Antibody control SCMXB-L98/79 Monkeypox Virus Antibody Rapid Test (Whole Blood/Serum/Plasma) IMXB-ACOR40298/79 Monkeypox Virus Antibody Rapid Test IMXB-ACO40298/79 Monkeypox Virus Antibody Test Cassette acrMXB402F98/79 Monkeypox Virus Antigen control SCMXG-D-L98/79 Monkeypox Virus Antigen Rapid Test IMXG-ACO40298/79 Monkeypox Virus Antigen Rapid Test IMXG-ACOR40298/79 Monkeypox Virus Antigen Test Cassette ACO-MXG-40298/79 MONO Control SCMONO-L98/79 MONO Rapid Test Cassette (Whole Blood/ Serum/ Plasma) IMO-R40298/79 Mononucleosis(MONO)Latex Reagents acrMONO001A98/79 MONORapid Test Cassette98/79 Multiplex Respiratory Antigen Control SCRTC-S98/79 Multiplex Respiratory Antigen Rapid Test (Swab) acrRTC595R98/79 Mycoplasma Pneumoniae Antigen Control SCMP-S98/79 Mycoplasma pneumoniae IgG/IgM Control SCMPGM-L98/79 Mycoplasma pneumoniae IgM Control SCMPM-L98/79 Mycoplasma pneumoniae/Adenovirus pneumoniae/ RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Cassette98/79 Norovirus Control SCNOR-D-L98/79 Norovirus+Rotavirus+Adenovirus+Astrovirus Combo Rapid Test IMVD-R64598/79 Norovirus+Rotavirus/Adenovirus+Astrovirus+Enterovirus Combo Rapid Test IMVD-ACO65598/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test IMVD-ACO64798/79 Norovirus/Astorvirus/Enterovirus Combo Control98/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test (Feces) INRA-R63798/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test Cassette INRA-RT63598/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test INRA-ACO63798/79 Norovirus/Rotavirus/Adenovirus Combo Test Cassette ACO-NRA-63598/79 Norovirus/Rotavirus/Adenovirus Control SCNRA-D-L98/79 Respiratory Antigen Rapid Combo Test (Swab) RTC5E98/79 Respiratory Antigen Rapid Combo Test acrMRA585R98/79 Respiratory Antigen Rapid Combo Test acrMRA595R98/79 Respiratory Antigen Rapid Combo Test IRTC-ACO58598/79 Respiratory Antigen Rapid Combo Test IRTC-ACO59598/79 Respiratory Infectious Diseases Rapid Test I(Analytes)-ACO5X798/79 Respiratory Infectious Diseases Rapid Test IAD-ACO50798/79 Respiratory Infectious Diseases Rapid Test IHMPV-ACO50798/79 Respiratory Infectious Diseases Rapid Test IIN-ACO50798/79 Respiratory Infectious Diseases Rapid Test IMP-ACO50798/79 Respiratory Infectious Diseases Rapid Test IMR-ACO50798/79 Respiratory Infectious Diseases Rapid Test INCP-ACO50798/79 Respiratory Infectious Diseases Rapid Test IPIV-ACO50798/79 Respiratory Infectious Diseases Rapid Test IRHV-ACO50798/79 Respiratory Infectious Diseases Rapid Test IRS-ACO50798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO52798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO53798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO54798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO55798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO56798/79 Rotavirus and Adenovirus Combo Rapid Test IRAC-ACO62798/79 Rotavirus Control SCROT-D-L98/79 Rotavirus/Adenovirus+Astrovirus Combo Rapid Test IRAA-ACO62598/79 RPR Reagents5 refs98/79 RSV and SARS-CoV-2 Antigen Combo Rapid Test98/79 RSV Control SCRSV-S98/79 RSV Rapid Test Cassette (Nasopharyngeal swab/Nasal Aspirate)98/79 RSV Test Cassette (Nasopharyngeal Swab/Nasal Aspirate)98/79 RSV/Influenza A+B Control SCRI-S98/79 RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 RSVRapid Test Cassette98/79 S. pneumoniae/L. pneumophila Control2 refs98/79 Salmonella paratyphi Control98/79 Salmonella typhi Antigen Control98/79 SARS-CoV-2 (COVID-19) Antigen Rapid Test (Swab)98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Control98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test2 refs98/79 SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma)98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma)98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Contro98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test2 refs98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Control98/79 Scrub Typhus IgG/IgM Control2 refs98/79 Strep A Rapid Test Cassette (Throat Swab)2 refs98/79 Strep A Rapid Test Cassette ISTB-R50298/79 Strep A Rapid Test Dipstick (Throat Swab)2 refs98/79 Strep A Test Cassette (Throat Swab)98/79 Strep ARapid Test Cassette (Control Linein Red)98/79 Strep B Rapid Test Cassette (Swab) ISB-R50298/79 Strep B Rapid Test Cassette (Swab) ISB-50298/79 Strep B Rapid Test Dipstick (Swab)98/79 Streptococcus pneumoniae Control2 refs98/79 Streptococcus pneumoniae Test Cassette (Urine)98/79 Streptococcuspneumoniae Antigen Rapid Test Cassette98/79 Syphilis Control SCSYP-L98/79 Syphilis Rapid Test Cassette (Whole Blood/Serum/Plasma) ISY-R40298/79 Syphilis Rapid Test Cassette (Serum/Plasma) ISY-R30298/79 Syphilis Rapid Test Cassette ISY-30298/79 Syphilis Rapid Test Cassette ISY-40298/79 Syphilis Rapid Test Cassette SYP2C98/79 Syphilis Rapid Test Dipstick (Serum/Plasma)98/79 Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma)98/79 Syphilis Rapid Test ISY-ACO10298/79 Syphilis Test Kit (CLIA)98/79 Tetanus Control SCTET-D-L98/79 TPHA Reagents3 refs98/79 Trichomonas Vaginalis Control SCTV-D-L98/79 Tuberculosis Control98/79 Vibrio cholerae O1/O139 Control98/79 Zika IgG/IgM Control SCZIB-L98/79 Zika NS1 Control98/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain)	China	Adenovirus + RSV Control L51-AR02S98/79 Adenovirus Control L51-AD01PR98/79 Adenovirus pneumoniae and RSV Combo Assay F11-AR01C598/79 Adenovirus pneumoniae Antigen Control L51-AD01S98/79 Adenovirus&RSV Combo Rapid Test L11-AR02C598/79 177 others Adenovirus&RSV&HMPV&HPIV&Flu A+B Combo Antigen Control98/79 Adenovirus&RSV&HMPV&Influenza A+B Combo Antigen Control98/79 Adenovirus&RSV&HMPV&SARS-CoV-2&Influenza A+B Combo Control98/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test L11-ARI03C598/79 Adenovirus/Rotavirus Control L51-AR02PR98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/Influenza A+B Control L51-ARI03S98/79 Astrovirus Control L51-AS01PR98/79 Brucella Abortus Control2 refs98/79 Campylobacter Control L51-CAM01PR98/79 Candida Albicans Control L51-CA01PR98/79 Chagas Control L51-CHA01P98/79 Chikungunya IgG/IgM Control L51-CHI01P98/79 Chikungunya IgG/IgM Control L51-CHI01PR98/79 Chikungunya IgG/IgM Control L51-CHI01R98/79 Clostridium difficile GDH Assay F11-CDG01C698/79 Clostridium difficile GDH Control L51-CDG01PR98/79 Clostridium difficile GDH Rapid Test L11-CDG01C698/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test L11-CD03C698/79 Clostridium difficile GDH+Toxin A+Toxin B Control L51-CD03PR98/79 Clostridium difficile GDH+Toxin A/B Assay F11-CD01C698/79 Clostridium difficile Toxin A + Toxin B Control L51-CDT02PR98/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test L11-CDT02C698/79 Clostridium difficile Toxin A/ toxin B Combo Assay F11-CDT01C698/79 Clostridium difficile Toxin A/Toxin B Combo Assay F11-CDT02C698/79 COVID-19 Antigen Assay98/79 COVID-19 S-RBD IgG Quantitative Assay98/79 Cryptococcus Antigen Control L51-CRG01PR98/79 Cryptosporidium and Giardia lamblia Control L51-CG02PR98/79 Cryptosporidium Control L51-CR01PR98/79 Dengue IgG/IgM Control L51-DEN01R98/79 Dengue NS1 Control3 refs98/79 EBNA IgG Rapid Test L11-EBG01C498/79 EBV VCA and EBNA IgG Combo Rapid Test L11-EBV02C498/79 EBV VCA IgG Rapid Test L11-EBA01C498/79 Entamoeba Histolytica Control L51-EH01PR98/79 Entamoeba/Giardia/Crypto Control2 refs98/79 Fluorescence lmmunoassay Control (Clostridium difficile GDH)98/79 Fluorescence lmmunoassay Control (Clostridium difficile GDH+Toxin A/B)98/79 Fluorescence lmmunoassay Control (Dengue IgG/IgM)98/79 Fluorescence lmmunoassay Control (Dengue NS1)98/79 Fluorescence lmmunoassay Control (H. pylori Antigen)98/79 Fluorescence lmmunoassay Control (HBsAb)98/79 Fluorescence lmmunoassay Control (HBsAg)98/79 Fluorescence lmmunoassay Control (HCV)98/79 Fluorescence lmmunoassay Control (Influenza A+B)98/79 Fluorescence lmmunoassay Control (Legionella pneumophila)98/79 Fluorescence lmmunoassay Control (Rotavirus and Adenovirus Combo)98/79 Fluorescence lmmunoassay Control (RSV)98/79 Fluorescence lmmunoassay Control (SARS-CoV-2 Ag/Influenza A+B)98/79 Fluorescence lmmunoassay Control (SARS-CoV-2 Antigen)98/79 Fluorescence lmmunoassay Control (Strep A)98/79 Fluorescence lmmunoassay Control (Streptococcus pneumoniae)98/79 Fluorescence lmmunoassay Control (Syphilis)98/79 Giardia Lamblia Control L51-GL01PR98/79 Gonorrhea Control98/79 H. pylori Antibody Control L51-HP01R98/79 H. pylori Antigen Control L51-HPG01PR98/79 H.pylori Antigen Control L51-HP01S98/79 H1N1 Antigen Rapid Test2 refs98/79 HPIV Control98/79 HPV L51-HPV01S98/79 HSV 1/2 IgG Rapid Test2 refs98/79 HSV 1/2 IgG/IgM Rapid Test4 refs98/79 HSV 1/2 IgM Rapid Test2 refs98/79 Human Metapneumovirus Control L51-HMPV01PR98/79 Influenza A Control L51-FLA01S98/79 Influenza A Rapid Test L11-FLA01C598/79 Influenza A+B Assay F11-FLU01C598/79 Influenza A+B Control L51-FLU01S98/79 Influenza A/B+H1N1 Combo Control98/79 Influenza A/B+H1N1 Combo Rapid Test98/79 Legionella pneumophila Assay98/79 Legionella pneumophila Control2 refs98/79 Legionella pneumophila Rapid Test98/79 Leptospira IgG/IgM Control L51-LEP01PR98/79 Leptospira IgG/IgM Control L51-LEP01R98/79 Malaria P.f. Control L51-MPF01P98/79 Malaria P.f. Rapid Test L11-MAF01A498/79 Malaria P.f./ Pan Control L51-MPN02P98/79 Malaria P.f./P.v. /Pan Rapid Test L11-MPVF01C498/79 Malaria P.f./P.v. Control L51-MPV02P98/79 Malaria P.f./P.v./Pan Assay F11-MAL01C498/79 Malaria P.f./P.v./Pan Control L51-MPVF03P98/79 Measles IgG/IgM Antibody Control L51-MEA01PR98/79 Monkeypox Virus Antibody Assay F11-MXB01C498/79 Monkeypox Virus Antibody Control L51-MXB01R98/79 Monkeypox Virus Antigen Assay F11-MXG01C298/79 Monkeypox Virus Antigen Assay F11-MXG01C498/79 Monkeypox Virus Antigen Control L51-MXG01PR98/79 MONO Control L51-MON01R98/79 MONO Rapid Test L11-MON01C498/79 Multiplex Respiratory Antigen Control (Adeno/HPIV/RSV/COVID-19/MP/RhV/Flu B/Flu A/HMPV)98/79 Multiplex Respiratory Antigen Rapid Test L11-RT905C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC02C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC03C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC04C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC05C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC06C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC07C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTCXXC598/79 Mycoplasma Pneumoniae Antigen Control L51-MP01S98/79 Mycoplasma pneumoniae IgG/IgM Control L51-MPB01R98/79 Mycoplasma pneumoniae IgM Control L51-MPM01R98/79 Norovirus Control L51-NO01PR98/79 Norovirus, Rotavirus and Adenovirus Combo Rapid Test L11-NRA02C698/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test L11-NRAA03C698/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test L11-NRAA03F698/79 Norovirus,Rotavirus,Adenovirus,Astrovirus Control L51-NRAA04PR98/79 Norovirus/Rotavirus/Adenovirus Control L51-NRA03PR98/79 One Step Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Test98/79 One Step Adenovirus/RSV/HMPV/Influenza A+B Combo Test98/79 One Step Dengue/Chikungunya/Zika Combo Test98/79 One Step Dengue/Zika/Chikungunya Combo Test98/79 One Step Influenza A+B Test98/79 One Step Malaria Antibody Test98/79 One Step Monkeypox Virus Antibody Test98/79 One Step Monkeypox Virus Antigen Test98/79 One Step Norovirus, Rotavirus and Adenovirus Combo Test98/79 One Step SARS-CoV-2 and M.pneumoniae IgG Combo Test98/79 One Step SARS-CoV-2 Antigen Test2 refs98/79 One Step SARS-CoV-2 Antigen Test (Oral Fluid)98/79 One Step SARS-CoV-2 IgG Test2 refs98/79 One Step SARS-CoV-2 IgG/IgM Test2 refs98/79 One Step SARS-CoV-2 Neutralization Antibody Test98/79 One Step Syphilis Test98/79 One Step Clostridium difficile GDH+ Toxin A +Toxin B Combo Test98/79 Respiratory Syncytial Virus (RSV) Assay F11-RSV01C598/79 Rotavirus and Adenovirus Assay F11-RAC01C698/79 Rotavirus and Adenovirus Combo Rapid Test L11-RAC01C698/79 Rotavirus and Adenovirus Combo Rapid Test L11-RAC01F698/79 Rotavirus Control L51-RO01PR98/79 RSV Control L51-RSV01S98/79 RSV&Influenza A+B Combo Rapid Test L11-RI02C598/79 RSV/Influenza A+B Control L51-RI02S98/79 S. pneumoniae/L. pneumophila Control2 refs98/79 Salmonella paratyphi Control98/79 Salmonella Typhi Antigen Control98/79 SARS-CoV-2 Ag/Influenza A+B Combo Assay98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test98/79 SARS-CoV-2 and Influenza A+B Combo Control98/79 SARS-CoV-2 and M.pneumoniae IgG/IgM Combo Rapid Test98/79 SARS-CoV-2 Antigen (Swab) Control98/79 SARS-CoV-2 Antigen Assay98/79 SARS-CoV-2 Antigen Control98/79 SARS-CoV-2 IgG/IgM Assay98/79 SARS-CoV-2 Rapid Antigen Test98/79 SARS-CoV-2 Rapid Antigen Test (Oral Fluid)98/79 SARS-CoV-2 S-RBD IgG Antibody Assay98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Control98/79 SARS-CoV-2/InfluenzaA+B/RSV/Adenovirus Control98/79 Scrub Typhus IgG/IgM Control2 refs98/79 Strep A Assay F11-STA01C598/79 Strep A Control L51-STA01R98/79 Strep A Rapid Test L11-ST01A598/79 Strep A Rapid Test L11-ST01C598/79 Strep A Rapid Test L11-STB01A598/79 Strep A Rapid Test L11-STB01C598/79 Strep B Control L51-SB01R98/79 Strep B Rapid Test L11-SB01A598/79 Streptococcus pneumoniae Antigen Rapid Test98/79 Streptococcus pneumoniae Assay98/79 Streptococcus pneumoniae Control2 refs98/79 Syphilis Assay F11-SYP01C498/79 Syphilis Control L51-SYP01P98/79 Syphilis Control L51-SYP01R98/79 Tetanus Control L51-TET01PR98/79 Trichomonas Vaginalis Control L51-TV01PR98/79 Tuberculosis Control98/79 Vibrio cholerae O1/O139 Control98/79 Zika IgG/IgM Control L51-ZIB01R98/79 Zika NS1 Control98/79	– 98/79	Website info@kylinew.com EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) and 1 other	United Kingdom (ex Northern Ireland)	Adenovirus + RSV Control D-S-CARC98/79 Adenovirus Control D-PL-CADE98/79 Adenovirus pneumoniae and RSV Combo Test Device- Nasopharyngeal Swab D-FIARNSD2098/79 Adenovirus pneumoniae Antigen Control D-S-CADE98/79 Adenovirus pneumoniae/RSV/Influenza A+B Combo Test Device-Nasopharyngeal Swab D-FIARID2098/79 151 others Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19 Combo Test Device-Nasopharyngeal Swab98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Device-Nasopharyngeal Swab98/79 Adenovirus/Rotavirus Control D-PL-CAR98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Control98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test Device-Swab98/79 Adenovirus/RSV/HMPV/Influenza A+B/COVID-19 Combo Rapid Test Device-Swab98/79 Adenovirus/RSV/Influenza A+B Control D-S-CARI98/79 Astrovirus Control D-PL-CAS98/79 Brucella Abortus Control2 refs98/79 C.difficile GDH + Toxin A + Toxin B Combo Rapid Test Device – Feces D-CDGTABD1098/79 Campylobacter Control D-PL-CCAM98/79 Candida Albicans Control D-PL-CCA98/79 Chagas Control D-P-CCHA98/79 Chikungunya control D-L-CCHIGM98/79 Chikungunya IgG/IgM Antibody Control D-PL-CCHIGM98/79 Clostridium difficile GDH + Toxin A + Toxin B Control D-PL-CCD98/79 Clostridium difficile GDH Control D-PL-CCDG98/79 Clostridium difficile GDH Test Device-Feces D-FICLOSD1098/79 Clostridium difficile GDH Test Device-Feces D-FICLOSD2598/79 Clostridium difficile GDH+Toxin A/B Test Device-Feces D-FICDGTABD1098/79 Clostridium difficile GDH+Toxin A/B Test Device-Feces D-FICDGTABD2598/79 Clostridium difficile Toxin A+ Toxin B Control D-PL-CCDT98/79 Clostridium difficile Toxin A/Toxin B Combo Test Device-Feces D-FICDTABD1098/79 Clostridium difficile Toxin A/Toxin B Combo Test Device-Feces D-FICDTABD2598/79 COVID-19 Ag/Influenza A+B Combo Test Device – Nasopharyngeal Swab98/79 COVID-19 Ag/Influenza A+B Control98/79 COVID-19 and Influenza A+B Antigen Combo Control98/79 COVID-19 Antigen Control98/79 COVID-19 Antigen Rapid Test Device-Nasopharyngeal Swab2 refs98/79 COVID-19 IgG/IgM Test Device -Finger Prick WB, WB/S/P2 refs98/79 COVID-19 S-RBD IgG Antibody Test Device -WB/S/P2 refs98/79 Cryptosporidium Antigen Control D-PL-CCRY98/79 Cryptosporidium Control D-L-CCRY98/79 Dengue IgG/IgM Rapid Test Device -WB/S/P98/79 Dengue Combo(NS1+IgG/IgM)+Chikungunya IgG/IgM+Zika IgG/IgM Rapid Test Device98/79 Dengue IgG&IgM/Zika IgG&IgM/Chikungunya IgG/Chikungunya IgM Combo Rapid Test Device D-DGMCMD2098/79 Dengue IgG/IgM Control D-L-CDEGM98/79 Dengue IgG/IgM Control D-P-FIDEN98/79 Dengue NS1 Control4 refs98/79 Dengue NS1 Rapid Test Device-WB/S/P98/79 Dengue/Zika/Chikungunya Combo Rapid Test Device-WB/S/P98/79 EBV VCA IgA Rapid Test Device-WB/S/P98/79 Entamoeba Histolytica Control D-PL-CEH98/79 Entamoeba/Giardia/Crypto Control2 refs98/79 FLU A+B Control98/79 Giardia Lamblia Control D-PL-CGL98/79 Gonorrhea Control98/79 H. pylori Antigen Control D-P-FIHPG98/79 H.pylori Ag Control D-S-CHPG98/79 H.pylori Antibody Control D-L-CHPB98/79 H.pylori Antigen Control D-PL-CHPG98/79 HAV IgM Rapid Test Device – WB/S/P98/79 HAV IgM Rapid Test S/P D-HAVMD2098/79 HPV Antigen Control D-S-CHPV98/79 Human Metapneumovirus Antigen Control D-PL-HMPV98/79 Influenza A Rapid Test Device -Swab/Nasal Aspirate98/79 Influenza A Rapid Test Strip – Swab/Nasal Aspirate98/79 Influenza A+B Control D-S-CFLAB98/79 Influenza A+B Rapid Test Device – Swab/Nasal Aspirate98/79 Influenza A+B Rapid Test Device-Swab D-RINFABD2598/79 Influenza A+B Rapid Test Strip – Swab/Nasal Aspirate2 refs98/79 Influenza A+B Test Device -Swab D-FIIABD2098/79 Influenza A/B+H1N1 Control98/79 Legionella pneumophila Control5 refs98/79 Legionella pneumophila Test Device -Urine2 refs98/79 Malaria P.f. Control D-P-CMPF98/79 Malaria P.f./P.v. Control D-P-CMPV98/79 Malaria P.f./P.v./Pan Control D-P-CMPVF98/79 Malaria P.f./P.v./Pan Rapid Test Device – WB98/79 Malaria P.f./P.v./Pan Test Device--WB2 refs98/79 Malaria P.f./Pan Control D-P-CMPN98/79 Malaria Pf Rapid Test Strip – WB98/79 Monkeypox Virus Antibody Control D-L-CMPOX98/79 Monkeypox Virus Antibody Rapid Test--Whole Blood/Serum/Plasma D-MPOXD2598/79 Monkeypox Virus Antigen Control D-PL-CMPOXAG98/79 Monkeypox Virus Antigen Rapid Test-Whole Blood/Serum/Plasma D-MPOXAGD2598/79 Monkeypox Virus Antigen Test Device-Fingerstick WB, WB/S/P/Rash Exudate Swab/Throat Swab98/79 MONO Control D-L-CMONO98/79 MONO Rapid Test Device -WB/S/P2 refs98/79 Multiplex 5 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Multiplex 6 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Multiplex 7 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Multiplex 8 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Multiplex 9 Respiratory Antigen Rapid Test Device-Swab2 refs98/79 Multiplex Respiratory Antigen Control D-S-CRT998/79 Mycoplasma Pneumoniae Antigen Control D-S-CMP98/79 Mycoplasma pneumoniae IgG/IgM Control D-L-CMPGM98/79 Mycoplasma pneumoniae IgM Control D-L-CMPM98/79 Mycoplasma pneumoniae/Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Device-Nasopharyngeal Swab98/79 Norovirus Control D-PL-CNOR98/79 Norovirus+Rotavirus/Adenovirus+Astrovirus+Enterovirus Combo Rapid Test Device-Feces D-NRAAED1098/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Device - Feces D-NRAAD0198/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Device - Feces D-NRAAD1098/79 Norovirus/Rotavirus/Adenovirus Combo Test Device-Feces D-FINRAD1098/79 Norovirus/Rotavirus/Adenovirus Combo Test Device-Feces D-FINRAD2598/79 Norovirus/Rotavirus/Adenovirus Control D-PL-CNRA98/79 Rotavirus and Adenovirus Combo Control D-P-FIRAC98/79 Rotavirus and Adenovirus Test Device-Feces D-FIROAAGD1098/79 Rotavirus and Adenovirus Test Device-Feces D-FIROAAGD2598/79 Rotavirus Control D-PL-CROT98/79 RSV Control D-S-CRSV98/79 RSV Control D-S-FIRSV98/79 RSV Rapid Test Device-Nasopharyngeal swab/Nasal Aspirate98/79 RSV Test Device -Swab D-FIRSVD2098/79 RSV/HMPV Combo Rapid Test Device-Nasopharyngeal Swab98/79 RSV/HMPV/Adenovirus/HPIV/Influenza A+B Combo Rapid Test Device98/79 RSV/Influenza A+B Control D-S-CRI98/79 RSV/Influenza A+B/COVID-19 Combo Test Device-Nasopharyngeal Swab98/79 S. pneumoniae and L. pneumophila Control98/79 S. pneumoniae/L. pneumophila Control98/79 Salmonella paratyphi Antigen Control98/79 Salmonella typhi Antigen Control98/79 SARS-CoV-2 & Inﬂuenza A+B & RSV & Adenovirus & M.pneumoniae Antigen Combo Rapid Test98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test Device-Swab98/79 SARS-CoV-2 Antigen Control98/79 SARS-CoV-2 Antigen Control (Swab)98/79 SARS-CoV-2 Antigen Rapid Test Device – Swab2 refs98/79 SARS-CoV-2 Neutralization Antibody Rapid Test Devie-WB/S/P98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Control98/79 SARS-CoV-2/Influenza A+B/RSV/ Adenovirus/M. pneumoniae Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test Device-Nasopharyngeal Swab2 refs98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test-Nasopharyngeal Swab98/79 Scrub Typhus IgG/IgM Control2 refs98/79 Strep A Control D-L-CSTA98/79 Strep A Control D-P-FISTA98/79 Strep A Rapid Test Device -Throat Swab3 refs98/79 Strep A RTC Rapid Test Device – Throat Swab98/79 Strep A Test Device -Swab D-FISTRAS2098/79 Strep B Control D-L-CSTB98/79 Strep B Rapid Test Device – Swab D-STRBD2098/79 Strep B Rapid Test Strip – Swab D-STRBS2098/79 Streptococcus pneumoniae antigen Rapid Test Device – Urine98/79 Streptococcus pneumoniae Control3 refs98/79 Streptococcus pneumoniae Test Device -Urine2 refs98/79 Syphilis Control D-L-CSYP98/79 Syphilis Control D-P-CSYP98/79 Syphilis Control D-P-FISYP98/79 Syphilis Rapid Test Device -S/P D-RTPD4098/79 Syphilis Rapid Test Device – S/P D-TPSPD4098/79 Syphilis Rapid Test Device – WB/S/P2 refs98/79 Syphilis Rapid Test Strip – S/P D-TPSPS5098/79 Syphilis Rapid Test Strip – WB/S/P2 refs98/79 Syphilis Test Device -WB/S/P3 refs98/79 Syphilis Test Kit-human serum or plasma D-CITPK4098/79 Tetanus Control D-PL-CTET98/79 Trichomonas Vaginalis Control D-PL-CTV98/79 Tuberculosis Control98/79 Vibrio cholerae O1/O139 Control98/79 Zika IgG/IgM Control D-L-CZIB98/79 Zika NS1 Control98/79	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other	China	C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 1 test/kit98/79 C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 10 tests/kit98/79 C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 100 tests/kit98/79 C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 25 tests/kit98/79 C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 5 tests/kit98/79 141 others C.difficile GDH / Toxin A/B Combined Assay Kit(Colloidal Gold) 50 tests/kit98/79 C.difficile GDH Assay Kit(Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 C.difficile GDH Assay Kit(Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 C.difficile GDH Assay Kit(Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 C.difficile GDH Assay Kit(Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 C.difficile Toxin A/B Assay Kit(Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 C.difficile Toxin A/B Assay Kit(Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 C.difficile Toxin A/B Assay Kit(Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 C.difficile Toxin A/B Assay Kit(Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 1 test/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 10 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 100 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 25 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 5 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 50 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 7 tests/kit98/79 Dengue NS1 Antigen/IgM Antibody/IgG Antibody Combined Detection Kit (Colloidal Gold) 1 test/kit98/79 Dengue NS1 Antigen/IgM Antibody/IgG Antibody Combined Detection Kit (Colloidal Gold) 10 tests/kit98/79 Dengue NS1 Antigen/IgM Antibody/IgG Antibody Combined Detection Kit (Colloidal Gold) 100 tests/kit98/79 Dengue NS1 Antigen/IgM Antibody/IgG Antibody Combined Detection Kit (Colloidal Gold) 25 tests/kit98/79 Dengue NS1 Antigen/IgM Antibody/IgG Antibody Combined Detection Kit (Colloidal Gold) 5 tests/kit98/79 Dengue NS1 Antigen/IgM Antibody/IgG Antibody Combined Detection Kit (Colloidal Gold) 50 tests/kit98/79 Dengue Virus IgM/IgG Antibody Combined Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Dengue Virus IgM/IgG Antibody Combined Assay Kit (Fluorescence Immunochromatographic Assay) 20 tests/kit98/79 Dengue Virus IgM/IgG Antibody Combined Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Dengue Virus IgM/IgG Antibody Combined Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Dengue Virus IgM/IgG Antibody Combined Assay Kit (Fluorescence Immunochromatographic Assay)Dengue Virus IgM/IgG Antibody Combined Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Dengue Virus Non-Structural Protein 1 Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Dengue Virus Non-Structural Protein 1 Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Dengue Virus Non-Structural Protein 1 Assay Kit (Fluorescence Immunochromatographic Assay) 20 tests/kit98/79 Dengue Virus Non-Structural Protein 1 Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Dengue Virus Non-Structural Protein 1 Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 1 test/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 5 tests/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 1 test/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 10 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 100 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 25 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 5 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 50 tests/kit98/79 Group B Streptococcus Antigen Detection Kit (Colloidal Gold) 1 test/kit98/79 Group B Streptococcus Antigen Detection Kit (Colloidal Gold) 10 tests/kit98/79 Group B Streptococcus Antigen Detection Kit (Colloidal Gold) 100 tests/kit98/79 Group B Streptococcus Antigen Detection Kit (Colloidal Gold) 25 tests/kit98/79 Group B Streptococcus Antigen Detection Kit (Colloidal Gold) 5 tests/kit98/79 Group B Streptococcus Antigen Detection Kit (Colloidal Gold) 50 tests/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 1 test/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 10 tests/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 100 tests/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 25 tests/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 5 tests/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 50 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 20 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 20 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Hepatitis C Virus Antibody Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Hepatitis C Virus Antibody Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Hepatitis C Virus Antibody Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit2 refs98/79 Hepatitis C Virus Antibody Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 1 test/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 10 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 100 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 25 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 5 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 50 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 1 test/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 10 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 100 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 25 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 5 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 50 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 1 test/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 10 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 100 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 25 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 5 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 50 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 1 test/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 5 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 1 test/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 10 tests/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 100 tests/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 25 tests/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 5 tests/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 50 tests/kit98/79 Respiratory Syncytial Virus Antigen Assay Kit(Colloidal Gold) 1 test/kit98/79 Respiratory Syncytial Virus Antigen Assay Kit(Colloidal Gold) 10 tests/kit98/79 Respiratory Syncytial Virus Antigen Assay Kit(Colloidal Gold) 100 tests/kit98/79 Respiratory Syncytial Virus Antigen Assay Kit(Colloidal Gold) 25 tests/kit98/79 Respiratory Syncytial Virus Antigen Assay Kit(Colloidal Gold) 5 tests/kit98/79 Respiratory Syncytial Virus Antigen Assay Kit(Colloidal Gold) 50 tests/kit98/79 Rota/Adeno Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Rota/Adeno Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Rota/Adeno Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Rota/Adeno Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 SARS-CoV -2 Neutralizing Antibody Assay Kit (Colloidal Gold) 1 test/kit98/79 SARS-CoV -2 Neutralizing Antibody Assay Kit (Colloidal Gold) 100 tests/kit98/79 SARS-CoV -2 Neutralizing Antibody Assay Kit (Colloidal Gold) 25 tests/kit98/79 SARS-CoV -2 Neutralizing Antibody Assay Kit (Colloidal Gold) 50 tests/kit98/79 SARS-CoV-2 / Influenza Virus Antigen Combined Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 SARS-CoV-2 / Influenza Virus Antigen Combined Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 SARS-CoV-2 / Influenza Virus Antigen Combined Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 SARS-CoV-2 / Influenza Virus Antigen Combined Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 1 test/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 10 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 100 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 25 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 5 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 50 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) SF24007298/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) 1 test/kit98/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) 100 tests/kit98/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) 25 tests/kit98/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) 50 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 1 test/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 10 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 100 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 25 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 5 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 50 tests/kit98/79 Treponema Pallidum Antibody Rapid Detection Kit (Colloidal Gold) 1 test/kit98/79 Treponema Pallidum Antibody Rapid Detection Kit (Colloidal Gold) 10 tests/kit98/79 Treponema Pallidum Antibody Rapid Detection Kit (Colloidal Gold) 100 tests/kit98/79 Treponema Pallidum Antibody Rapid Detection Kit (Colloidal Gold) 25 tests/kit98/79 Treponema Pallidum Antibody Rapid Detection Kit (Colloidal Gold) 5 tests/kit98/79 Treponema Pallidum Antibody Rapid Detection Kit (Colloidal Gold) 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor Malaria Detection qPCR Kit CFP9898/79 ChainFor™3 refs ChainFor™ CFP69P10098/79 ChainFor™ H1N1 Detection qPCR Kit CFP6098/79 LyoSens™ LYO69WS2498/79 114 others PCPO27-01 PCPO28-01 PCPO29-01 PCPO30-01 PCPO31-01 PCPO32-01 PCPO33-01 PCPO34-01 PCPO35-01 PCPO44-01 RapidFor™40 refs RapidFor™ CMV Rapid Test Kit VMD12498/79 RapidFor™ CT + NG v2.0 Test Kit RapidFor™ Dengue IgG/IgM Rapid Test Kit (FIA) VMPO7298/79 RapidFor™ Dengue NS1 Ag Rapid Test Kit (FIA) VMPO7198/79 RapidFor™ Dengue NS1 Test Kit2 refs RapidFor™ H.pylori Ag Rapid Test Kit (FIA) VMPO6798/79 RapidFor™ H.Pylori v2.0 Test Kit RapidFor™ Influenza A H5 Test Kit2 refs RapidFor™ Malaria P.f. (HRP2) Rapid Test Kit VMD2098/79 RapidFor™ Malaria P.f. (pLDH) Rapid Test Kit VMD12798/79 RapidFor™ Malaria P.f. pLDH/HRP2 Test Kit RapidFor™ Monkeypox Virus Ag Rapid Test Kit VMD7398/79 RapidFor™ SARS-CoV-2 + FLU A/B + HPIV + RSV + ADV Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + MP + hMPV + HPIV + RhV Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + MP Test Kit3 refs RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + hMPV + HPIV Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + hMPV Test Kit3 refs RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + RhV + hMPV Test Kit3 refs RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV Test Kit5 refs RapidFor™ SARS-CoV-2 + FLU A/B + RSV + MP + HPIV Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + RSV + hMPV Test Kit2 refs RapidFor™ SARS-CoV-2 + FLU A/B + RSV Test Kit3 refs RapidFor™ SARS-CoV-2 + FLU A/B Test Kit6 refs RapidFor™ SARS-CoV-2 + RSV + ADV Test Kit3 refs RapidFor™ SARS-CoV-2 + RSV Test Kit2 refs RapidFor™ SARS-CoV-2 Test Kit2 refs RapidFor™ VMD04BD98/79 RapidFor™ VMD04BD50LA98/79 RapidFor™ VMD06BD98/79 RapidFor™ VMD06BDLA98/79 RapidFor™ VMD101BC98/79 RapidFor™ VMD101FD98/79 RapidFor™ VMD109STS RapidFor™ VMD110D98/79 RapidFor™ VMD112FD98/79 RapidFor™ VMD135FD98/79 RapidFor™ VMD138BC98/79 RapidFor™ VMD138FD98/79 RapidFor™ VMD141SC98/79 RapidFor™ VMD146BC98/79 RapidFor™ VMD146TD98/79 RapidFor™ VMD150FD98/79 RapidFor™ VMD150SC98/79 RapidFor™ VMD152FD98/79 RapidFor™ VMD152SC98/79 RapidFor™ VMD154SC98/79 RapidFor™ VMD155FD98/79 RapidFor™ VMD155SC2098/79 RapidFor™ VMD157FD98/79 RapidFor™ VMD157SC98/79 RapidFor™ VMD158FD98/79 RapidFor™ VMD158SC98/79 RapidFor™ VMD159FD98/79 RapidFor™ VMD159SC98/79 RapidFor™ VMD161SC98/79 RapidFor™ VMD16TD98/79 RapidFor™ VMD16TD0198/79 RapidFor™ VMD175FD98/79 RapidFor™ VMD176STS98/79 RapidFor™ VMD17BC98/79 RapidFor™ VMD17BC2098/79 RapidFor™ VMD17SC98/79 RapidFor™ VMD17TD98/79 RapidFor™ VMD17TD2098/79 RapidFor™ VMD187FD98/79 RapidFor™ VMD188SC98/79 RapidFor™ VMD21BD98/79 RapidFor™ VMD22BDLA98/79 RapidFor™ VMD28BDLA98/79 RapidFor™ VMD36DTS98/79 RapidFor™ VMD36STS98/79 RapidFor™ VMD38BDLA98/79 RapidFor™ VMD66FD98/79 RapidFor™ VMD66SC98/79 RapidFor™ VMD66TD98/79 RapidFor™ VMD71BC98/79 RapidFor™ VMD71FD98/79 RapidFor™ VMD71SC98/79 RapidFor™ VMD71SD0198/79 RapidFor™ VMD78FD98/79 RapidFor™ VMD78SC98/79 RapidFor™ VMD79FD98/79 RapidFor™ VMD79SC0198/79 RapidFor™ VMD79TD0198/79 RapidFor™ VMD80BC98/79 RapidFor™ VMD80FD98/79 RapidFor™ VMD81SC98/79 RapidFor™ VMD95FD98/79 RapidFor™ VMD95SC98/79 RapidFor™ VMD95TD98/79 RapidFor™ VMPO126ED98/79 RapidFor™ VMPO126UP98/79 RapidFor™ VMPO67GD98/79 RapidFor™ VMPO73EP98/79 RapidFor™ VMPO74ED98/79 RapidFor™ VMPO74EP98/79 RapidFor™ VSCD02SC98/79 RapidFor™ VSCD02SC0198/79 RapidFor™ VSCD02ST0198/79 RapidFor™ VSCD08ST0198/79 RapidFor™Monkeypox Virus Ab Rapid Test Kit VMD7498/79 WellFor Strep A v2.0 Test Kit VMD150ST0198/79 WellFor VSCD10ST0198/79	B, C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş	Türkiye	Anti-HCV Test Eco TIHC0298/79 Anti-HCV Test IHC0198/79 Anti-HCV Test IHC0298/79 Anti-HCV Test Plus TIHC0214098/79 Anti-HCV Test Pro TIHC0234098/79 99 others Anti-HCV Test RTHC0198/79 Anti-HCV Test RTHC0298/79 Anti-HCV Test Single TIHC0220598/79 Anti-HCV Test Single TIHC0222098/79 Anti-HCV Test THC0198/79 Anti-HCV Test THC0298/79 Anti-HCV Test TIHC0198/79 Anti-HIV 1/2 Test7 refs98/79 Anti-HIV 1/2 Test Eco98/79 Anti-HIV 1/2 Test Plus98/79 Anti-HIV 1/2 Test Pro98/79 Anti-HIV 1/2 Test Single2 refs98/79 Anti-Syphilis Test Eco TITP0298/79 Anti-Syphilis Test ITP0198/79 Anti-Syphilis Test ITP0298/79 Anti-Syphilis Test Plus TITP0214098/79 Anti-Syphilis Test Pro TITP0234098/79 Anti-Syphilis Test RTTP0198/79 Anti-Syphilis Test RTTP0298/79 Anti-Syphilis Test Single TITP0220598/79 Anti-Syphilis Test Single TITP0222098/79 Anti-Syphilis Test TITP0200198/79 Anti-Syphilis Test TITP0201098/79 Anti-Syphilis Test TTP0198/79 Anti-Syphilis Test TTP0298/79 Covid-19 Ag Test8 refs98/79 Dengue IgG/IgM Test IDG0198/79 Dengue IgG/IgM Test RTDG0198/79 Dengue IgG/IgM Test TDG0198/79 Dengue IgG/IgM Test TIDG0198/79 Dengue IgG/IgM Test TIDG0100198/79 Dengue IgG/IgM Test TIDG0101098/79 Dengue NS1 Test6 refs98/79 Dengue NS1, IgG/IgM Test6 refs98/79 H.Pylori Ab Test IHP0198/79 H.Pylori Ab Test IHP0298/79 H.Pylori Ab Test RTHP0198/79 H.Pylori Ab Test RTHP0298/79 H.Pylori Ab Test THP0198/79 H.Pylori Ab Test THP0298/79 H.Pylori Ab Test TIHP0298/79 H.Pylori Ab Test TIHP0200198/79 H.Pylori Ab Test TIHP0201098/79 H.Pylori Ag Test IHP0398/79 H.Pylori Ag Test RTHP0398/79 H.Pylori Ag Test THP0398/79 H.Pylori Ag Test TIHP0398/79 H.Pylori Ag Test TIHP0300198/79 H.Pylori Ag Test TIHP0301098/79 HBsAg Test Eco TIHB0498/79 HBsAg Test IHB0398/79 HBsAg Test IHB0498/79 HBsAg Test Plus TIHB0414098/79 HBsAg Test Pro TIHB0434098/79 HBsAg Test RTHB0398/79 HBsAg Test RTHB0498/79 HBsAg Test Single TIHB0420598/79 HBsAg Test Single TIHB0422098/79 HBsAg Test THB0398/79 HBsAg Test THB0498/79 HBsAg Test TIHB0398/79 Influenza A/B Test IIAB0198/79 Influenza A/B Test RTIAB0198/79 Influenza A/B Test TIAB0198/79 Influenza A/B Test TIIAB0100198/79 Influenza A/B Test TIIAB0101098/79 Influenza A/B Test, Eco TIIAB0198/79 Influenza A/B Test, Plus TIIAB0114098/79 Influenza A/B Test, Single TIIAB0120598/79 Influenza A/B Test, Single TIIAB0122098/79 Malaria Test IML0198/79 Malaria Test RTML0198/79 Malaria Test TIML0198/79 Malaria Test TIML0100198/79 Malaria Test TIML0101098/79 Malaria Test TML0198/79 Rotavirus Adenovirus Test IRA0198/79 Rotavirus Adenovirus Test RTRA0198/79 Rotavirus Adenovirus Test TIRA0198/79 Rotavirus Adenovirus Test TIRA0100198/79 Rotavirus Adenovirus Test TIRA0101098/79 Rotavirus Adenovirus Test TRA0198/79 RSV Test TIRSV0102598/79 Sars-CoV-2 + Flu A/B + RSV + ADV Test98/79 Sars-CoV-2 + Flu A/B + RSV Test98/79 Sars-CoV-2 + Flu A/B Test98/79 SARS-CoV-2 IgM/IgG Ab Test4 refs98/79 Strep A Test ISA0198/79 Strep A Test ISA10198/79 Strep A Test RTSA0198/79 Strep A Test RTSA10198/79 Strep A Test TISA0101098/79 Strep A Test TISA10198/79 Strep A Test TSA0198/79 Strep A Test TSA10198/79 Strep A Test, Eco TISA0198/79 Strep A Test, Plus TISA0114098/79 Strep A Test, Single TISA0120598/79 Strep A Test, Single TISA0122098/79	– 98/79	Website info@turklab.com.tr EUDAMED record Report an error
Abbott FDA EU representative : Emergo Europe B.V. (Netherlands) and 2 others	Germany, Japan, South Korea, United States	Alere™ Malaria Ag P.f 05FK14098/79 Alere™ Malaria Ag P.f 05FK14198/79 Alere™ Malaria Ag P.f 05FK14398/79 BinaxNOW™ Influenza A & B Card 416-00098/79 BinaxNOW™ Malaria (25T) 660-00098/79 94 others BinaxNOW™ Malaria 6600598/79 BinaxNOW™ RSV Card (22T) 430-02298/79 BinaxNOW™ RSV Card (42T) 430-00098/79 BinaxNOW™ RSV Control Swab Kit (10 POS+10 NEG) 430-08098/79 BinaxNOW™ Strep A Control Swab Kit (5 POS+5 NEG) 730-01098/79 BinaxNOW™ Streptococcus pneumoniae Antigen Card (12T) 710-01298/79 BinaxNOW™ Streptococcus pneumoniae Antigen Card (22T) 710-10098/79 Bioline™ Dengue Duo 11FK452 refs98/79 Bioline™ Dengue Duo 11FK462 refs98/79 Bioline™ Dengue IgG/IgM 11FK1098/79 Bioline™ Dengue IgG/IgM WB 11FK202 refs98/79 Bioline™ Dengue NS1 Ag 11FK5098/79 Bioline™ H.pylori 04FK1098/79 Bioline™ H.pylori 04FK1198/79 Bioline™ HCV 02FK10CE98/79 Bioline™ HCV 02FK16CE98/79 Bioline™ HCV 02FK17CE98/79 Bioline™ HIV 1/2 3.0 03FK10CE2 refs98/79 Bioline™ HIV 1/2 3.0 03FK16CE2 refs98/79 Bioline™ Influenza Ag A/B/A (H1N1) 19FK3198/79 Bioline™ Influenza Ag A/B/A (H1N1) 19FK3298/79 Bioline™ Influenza Ag A/B/A(H1N1) Pandemic 19FK3198/79 Bioline™ Influenza Ag A/B/A(H1N1) Pandemic 19FK3298/79 Bioline™ Influenza Antigen 19FK1198/79 Bioline™ Influenza Antigen 19FK122 refs98/79 Bioline™ Influenza Ultra 19FK133 refs98/79 Bioline™ Malaria Ag P.f (HRP2/pLDH) 05FK9098/79 Bioline™ Malaria Ag P.f 05FK502 refs98/79 Bioline™ Malaria Ag P.f/P.f/P.v98/79 Bioline™ Malaria Ag P.f/P.f/P.v 05FK12098/79 Bioline™ Malaria Ag P.f/P.f/P.v 05FK12398/79 Bioline™ Malaria Ag P.f/P.v 05FK8098/79 Bioline™ Malaria Ag P.f/Pan 05FK602 refs98/79 Bioline™ Malaria Ag P.f/Pan 05FK6198/79 Bioline™ Malaria Ag P.f/Pan 05FK6398/79 Bioline™ RSV 40FK122 refs98/79 Bioline™ Strep A98/79 Bioline™ Strep A 45FK1298/79 Bioline™ Syphilis 3.0 06FK102 refs98/79 Bioline™ Syphilis Fast 3.0 06FK1198/79 Bioline™ Syphilis Fast 3.0 06FK1298/79 CheckNow™ 455340902398/79 CheckNow™ 456342902398/79 CheckNow™ 456381902398/79 Determine2 refs98/79 Determine HIV Early Detect98/79 Determine Syphilis TP 30T 7D244298/79 ID NOW™ Influenza A & B 2 (24T) 427-00098/79 ID NOW™ Strep A 2 (24T) 734-00098/79 NxTek™ Eliminate Malaria Pf 05FK14098/79 Panbio Dengue Early Rapid 01PF2098/79 Panbio™ 455556902298/79 Panbio™ 455996902298/79 Panbio™ 455997902298/79 Panbio™ 456339902298/79 Panbio™ 456340902298/79 Panbio™ 456751902298/79 Panbio™ AF41FK11CON98/79 Panbio™ AF41FK11CONA98/79 Panbio™ AF62FK11CONA98/79 Panbio™ AF62FK11CONB98/79 Panbio™ AF62FK11CONC98/79 Panbio™ AF62FK11COND98/79 Panbio™ Dengue Early Rapid98/79 Panbio™ Dengue Early Rapid 01PF2098/79 SD BIOLINE Dengue Duo 11FK4598/79 SD BIOLINE Dengue Duo 11FK4698/79 SD BIOLINE Dengue IgG/IgM 11FK1098/79 SD BIOLINE Dengue IgG/IgM WB 11FK2098/79 SD BIOLINE Dengue NS1 Ag 11FK5098/79 SD BIOLINE H.pylori 04FK1098/79 SD BIOLINE H.pylori 04FK1198/79 SD BIOLINE Influenza Ag A/B/A(H1N1) Pandemic 19FK3198/79 SD BIOLINE Influenza Antigen 19FK1198/79 SD BIOLINE Influenza Antigen 19FK1298/79 SD BIOLINE Influenza Ultra 19FK1398/79 SD BIOLINE Malaria Ag P.f (HRP2/pLDH) 05FK9098/79 SD BIOLINE Malaria Ag P.f (HRP2/pLDH) 05FK9398/79 SD BIOLINE Malaria Ag P.f 05FK502 refs98/79 SD BIOLINE Malaria Ag P.f 05FK5398/79 SD BIOLINE Malaria Ag P.f./Pan 05FK602 refs98/79 SD BIOLINE Malaria Ag P.f./Pan 05FK612 refs98/79 SD BIOLINE Malaria Ag P.f./Pan 05FK6398/79 SD BIOLINE Malaria Ag P.f./Pan 05FK6798/79 SD BIOLINE Malaria Ag P.f/P.f/P.v 05FK12098/79 SD BIOLINE Malaria Ag P.f/P.f/P.v 05FK12398/79 SD BIOLINE Malaria Ag P.f/P.v 05FK8098/79 SD BIOLINE Malaria Ag P.f/P.v 05FK8298/79 SD BIOLINE RSV 40FK1298/79 SD Bioline Strep A 45FK1298/79 SD BIOLINE Syphilis 3.0 06FK1098/79 SD BIOLINE Syphilis 3.0 06FK1198/79 SD BIOLINE Syphilis Fast 3.0 06FK1298/79 TestPack Plus Strep A with OBC98/79	– 98/79	Website EUDAMED record Report an error
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain)	United States	Adenovirus &RSV Combo Test SW25-ARC98/79 Adenovirus pneumoniae and RSV Combo FIA Test98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19 Combo FIA Test98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo FIA Test98/79 Adenovirus, RSV & Flu A+B Combo Test98/79 84 others Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Test98/79 Adenovirus/RSV/Influenza A+B Combo FIA Test98/79 Chikungunya/Zika Combo Test BSP25-CZ98/79 Clostridium difficile GDH & Toxin A &Toxin B Combo Test F35-CD98/79 Clostridium difficile GDH & Toxin A &Toxin B Combo Test F37-CD98/79 Clostridium difficile GDH FIA Test98/79 Clostridium difficile GDH Test F02-CDG98/79 Clostridium difficile GDH+Toxin A/B FIA Test98/79 Clostridium difficile GDH/Toxin A/Toxin B FIA Test98/79 Clostridium difficile Toxin A &Toxin B Combo Test F25-CDT98/79 Clostridium difficile Toxin A/Toxin B Combo FIA Test98/79 COVID-19 Ag/Influenza A+B Combo FIA Test98/79 COVID-19 Antigen FIA Test98/79 COVID-19 IgG/IgM FIA Test98/79 COVID-19 S-RBD IgG Antibody FIA Test98/79 Dengue/Chikungunya/Zika Combo Test BSP35-DCZ98/79 Dengue/Zika/Chikungunya Combo Test BSP45-DZC98/79 EBNA IgG Test BSP02-ENG98/79 EBV VCA & EBNA IgG Combo Test BSP25-ECN98/79 EBV VCA IgG Test BSP02-ECG98/79 Flu A Test2 refs98/79 FLU A+B FIA Test98/79 Flu A+B Test2 refs98/79 Flu A+B Test (Swab/Nasal Aspirate)98/79 Flu A/B & H1N1 Combo Test98/79 H1N1 Ag Test98/79 HSV 1/2 IgG Test2 refs98/79 HSV 1/2 IgG/IgM Test4 refs98/79 HSV 1/2 IgM Test2 refs98/79 Legionella pneumophila FIA Test98/79 Legionella pneumophila Test98/79 Malaria P.f. Test B01-MAL98/79 Malaria P.f. Test B02-MAL98/79 Malaria P.f./ P.v. /Pan Test B02-MPVF98/79 Malaria P.f./ P.v. Test B02-MPV98/79 Malaria P.f./ Pan Test B02-MPN98/79 Malaria P.f./P.v./Pan FIA Test98/79 Monkeypox Virus Ab Test BSP02-MXB98/79 Monkeypox Virus Ag FIA Test98/79 Monkeypox Virus Ag Test Q02-MXG98/79 MONO Test BSP02-MONO98/79 Multi-Respiratory Antigen Test SW55-RT998/79 Multi-Respiratory Antigen Test SW67-RTC98/79 Multi-Respiratory Antigen Test SW85-RTC98/79 Mycoplasma pneumoniae/Adenovirus pneumoniae/ RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo FIA Test98/79 Norovirus+Rotavirus, Adenovirus +Astrovirus+Enterovirus Combo Test F55-NRAAE98/79 Norovirus, Rotavirus & Adenovirus Combo Test F35-NRA98/79 Norovirus, Rotavirus & Adenovirus Combo Test F37-NRA98/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test F45-NRAA98/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test F47-NRAA98/79 Norovirus/Rotavirus/Adeno virus Combo FIA Test98/79 Rotavirus & Adenovirus Combo Test F02-RA98/79 Rotavirus & Adenovirus Combo Test F07-RA98/79 Rotavirus and Adenovirus FIA Test98/79 RSV FIA Test98/79 RSV Test SW02-RSV98/79 RSV&Flu A+B Combo Test98/79 RSV/Influenza A+B/COVID-19 Combo FIA Test98/79 SARS-CoV-2 & Flu A+B Ag Combo Test2 refs98/79 SARS-CoV-2 & M.pneumoniae IgG Combo Test98/79 SARS-CoV-2 & M.pneumoniae IgG/IgM Combo Test98/79 SARS-CoV-2 Ag Test5 refs98/79 SARS-CoV-2 IgG/IgM Test3 refs98/79 SARS-CoV-2 Neutralization Antibody Test98/79 SARS-CoV-2 S-RBD IgG Antibody Test98/79 SARS-CoV-2/Flu A+B/RSV Ag Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus Ag Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus/M.pneumoniae Ag Combo Test98/79 Strep A FIA Test98/79 Strep A Test SW01-STA98/79 Strep A Test SW01B-STA98/79 Strep A Test SW02-STA98/79 Strep A Test SW02B-STA98/79 Strep B Test SW01-STB98/79 Strep B Test SW02-STB98/79 Streptococcus pneumoniae Ag Test98/79 Streptococcus pneumoniae FIA Test98/79 Syphilis FIA Test98/79 Syphilis Test BSP01-SYP98/79 Syphilis Test BSP02-SYP98/79 Syphilis Test SP01-SYP98/79 Syphilis Test SP02-SYP98/79	– 98/79	info@acesolab.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	United States	AFAB01-AHG48E; AFAB01-AHG96E98/79 AFAB03-AHG48E; AFAB03-AHG96E; AFAB03D-AHG48E; AFAB03D-AHG96E98/79 AFAB03D-AHG48E; AFAB03D-AHG96E98/79 AIAH501D-AHG48E; AIAH501D-AHG96E98/79 CDGV01A-AHG4E98/79 78 others CDGVZK01-AHG4E98/79 Clostridium difficile Antigen GDH Rapid Test Cassette (Feces) GCCD(GDH)-602a98/79 Clostridium difficile GDH & Toxin A/B Rapid Test Cassette (Feces) GCCD-602a98/79 Clostridium difficile Toxin A&B Rapid Test Cassette (Feces) GCCD(Toxin A/B)-602a98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NA98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NN98/79 COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab) GCCOV(B117)-525a98/79 COVID-19 Ag Rapid Test Cassette (Oral Fluid) GCCOV-702a98/79 COVID-19 Antigen Control Kit GCCOV(Ag)-PN1098/79 COVID-19 Antigen Control Kit GCCOV(Ag)-PN2098/79 COVID-19 IgG/IgM CONTROL Kit GCCOV-PN1098/79 COVID-19 IgG/IgM CONTROL Kit GCCOV-PN2098/79 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402a98/79 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402Ba98/79 COVID-19+Flu A&B+RSV Ag Combo Rapid Test Cassette (Swab) GCFCR-T525Sa-DD98/79 COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) GCFC-T502a98/79 COVID-19/Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab) GCFCR-T525a98/79 COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) GCFCRA-T525a98/79 COVID-19/Flu A&B/RSV/Adeno Ag Control Kit GCFCRA-PN298/79 COVID-19/Flu A&B/RSV/Adeno/HPIV/HMPV/RhV/M. pneumoniae Ag Combo Rapid Test Cassette (Swab) GCRESA-T555a98/79 COVID-19/Flu A/Flu B/RSV/ADV/M.P Ag Combo Rapid Test Cassette (Swab) GCFCRAMP-T535a98/79 Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(ab)-402e98/79 Dengue IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(ab)-402c98/79 Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(NS)-402c98/79 Dengue NS1 Ag Rapid Test Cassette(Whole Blood/Serum/Plasma) GCDEN(NS)-402d98/79 Dengue NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN-425a98/79 Digital COVID-19 Ag Rapid Test (Swab) GCCOV-D503a98/79 Flu A Ag Rapid Test Cassette (Swab) GCFLU(A)-U502a98/79 Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab) GCFCRA-545a98/79 H. pylori Ab Rapid Test Cassette (Serum/Plasma) GCHP-302a98/79 H. pylori Ab Rapid Test Cassette (Whole blood/Serum/Plasma) GCHP-402a98/79 H. pylori Ag Control Kit GCHP-PN298/79 H. pylori Ag Rapid Test Cassette (Feces) GCHP-602a98/79 H. pylori Ag Rapid Test Cassette (Feces) GCHP-602Ca98/79 H. pylori Ag Rapid Test Strip (Feces) GCHP-601a98/79 H. pylori Ag Rapid Test Strip (Feces) GCHP-601Ca98/79 H.pylori Ag Rapid Test Device (Feces) GCHP-606a98/79 H. pylori Ab Rapid Test Strip (Serum/Plasma) GCHP-301a98/79 H. pylori Ab Rapid Test Strip (Whole blood/Serum/Plasma) GCHP-401a98/79 HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette) GCHCV-302a98/79 HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette) GCHCV-402a98/79 HIV 1/2 Human Immunodeficiency Virus Rapid Test (Serum/Plasma)(Cassette) GCHIV-302a98/79 HIV 1/2 Human Immunodeficiency Virus Rapid Test st (Whole blood/Serum/Plasma)(Cassette) GCHIV-402a98/79 Influenza A & B Ag Rapid Test Cassette (Swab) GCFLU(A/B)-502a98/79 Influenza A & B Ag Rapid Test Cassette (Swab) GCFLU(A/B)-502Ca98/79 Influenza A & B Ag Rapid Test Strip (Swab) GCFLU(A/B)-501a98/79 Influenza A (H5) Ag Rapid Test Cassette (Swab) GCFLU(AH5)-502a98/79 Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pv)-402a98/79 Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pan)-402a98/79 Malaria Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pan)-402a98/79 Malaria Pf Ag Rapid Test Cassette (Whole Blood) GCMAL(Pf)-402a98/79 Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma) GCMAL(pf/pv Ab)-302a98/79 Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma) GCMAL(pf/pv Ab)-402a98/79 Monkeypox Ag Rapid Test Cassette (Swab) GCMKP-502b98/79 Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMKP-402a98/79 Mononucleosis IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma) GCMON-425a98/79 Mononucleosis IgG/lgM Rapid Test Cassette(Serum/Plasma) GCMON-325a98/79 Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMON-402a98/79 Rapid COVID-19 Antigen Test Strip GCCOV-501a98/79 Rapid COVID-19+Influenza Antigen Test GCFC-525a98/79 RSV Antigen Rapid Test Cassette (Swab) GCRSV-502a98/79 RSV Antigen Rapid Test Cassette (Swab) GCRSV-502Ca98/79 SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab) FCCOV-502a98/79 SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab) GCCOV(Del)-T502a98/79 SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV(NAb)-402b98/79 Smart Rapid COVID-19 & Flu A/B Ag Test Device GCFC-T503a98/79 Smart Rapid COVID-19 Ag Test Device GCCOV-503a98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502a98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502Ca98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502CSa98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501a98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501Ca98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501CSa98/79 Syphilis Ab Rapid Test Cassette (Serum/Plasma) GCSYP-302a98/79 Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCSYP-402a98/79 Syphilis Ab Rapid Test Strip (Serum/Plasma) GCSYP-301a98/79 Syphilis Ab Rapid Test Strip (Whole Blood/Serum/Plasma) GCSYP-401a98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Tongzhoubio FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	2019-nCoV IgG/IgM Rapid Test98/79 Adenovirus control HSCADE-D-L98/79 Adenovirus&RSV Combo Rapid Test I055-502598/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test I056-503598/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 75 others Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Chikungunya and Dengue Combo Rapid Test I202-403598/79 Clostridium Difficile GDH Test Kit YI062-600298/79 Clostridium difficile Toxin A/ toxin B Combo Test Kit YI010-602598/79 Coronavirus (SARS-CoV-2) Ag Self Test98/79 COVID-19 Antigen Test Kit98/79 COVID-19 S-RBD IgG Antibody Test Kit98/79 EBNA IgG Rapid Test I076-400298/79 EBV VCA and EBNA IgG Combo Rapid Test I077-402598/79 EBV VCA IgG Rapid Test I075-400298/79 FLU A+B Test Kit98/79 H. pylori Antibody control HSCHPB-L98/79 H. pylori Antigen control HSCHPG-D-L98/79 H.Pylori Antibody Rapid Test I021-N4002-253 refs H1N1 Antigen Rapid Test2 refs98/79 HSV 1/2 IgG Rapid Test (S/P)98/79 HSV 1/2 IgG Rapid Test (WB/S/P)98/79 HSV 1/2 IgG/IgM Combo Rapid Test2 refs98/79 HSV 1/2 IgG/IgM Rapid Test (Serum/Plasma)98/79 HSV 1/2 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgM Rapid Test (Serum/Plasma)98/79 HSV 1/2 IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 Influenza A+B control HSCFLAB-S98/79 Influenza A/B+H1N1 Combo Rapid Test98/79 Legionella pneumophila Rapid Test98/79 Legionella pneumophila Test Kit98/79 Malaria P.f. Rapid Test I039-400198/79 Malaria P.f. Rapid Test I039-400298/79 Malaria P.f./ Pan Rapid Test I040-400298/79 Malaria P.f./P.v. Rapid Test I041-400298/79 Malaria P.f./P.v./Pan Rapid Test I042-400298/79 Malaria P.f./P.v./Pan Test Kit YI063-403598/79 Malaria P.f./Pan control HSCMPN-D98/79 Monkeypox Antibody Rapid Test I089-400298/79 Monkeypox Antigen Rapid Test I090-400298/79 Monkeypox Virus Antibody Test Kit YI067-400298/79 Monkeypox Virus Antigen Test Kit YI066-400298/79 Monkeypox Virus Real Time PCR-Kit98/79 MONO Rapid Test I049-400298/79 Multiplex Respiratory Virus Antigen Rapid Test I161-507598/79 Multiplex Respiratory Virus Antigen Rapid Test I161-5XX598/79 Mycoplasma pneumoniae Antigen control HSCMP-S98/79 Mycoplasma Pneumoniae IgG/IgM control HSCMPGM-L98/79 Mycoplasma Pneumoniae IgM control HSCMPM-L98/79 Norovirus, Rotavirus and Adenovirus Combo Rapid Test I009-603598/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Cup I011-604798/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test I011-604598/79 Rotavirus and Adenovirus control HSCRAC-D-L98/79 Rotavirus control HSCROT-D-L98/79 RSV Test Kit YI053-500298/79 RSV&Influenza A+B Combo Rapid Test I054-502598/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test98/79 SARS-CoV-2 and Influenza A+B Antigen Rapid Test98/79 SARS-CoV-2 and M.pneumoniae IgG Combo Rapid Test98/79 SARS-CoV-2 and M.pneumoniae IgG/IgM Combo Rapid Test98/79 SARS-CoV-2 and RSV Antigen Combo Rapid Test98/79 SARS-CoV-2 Antigen Test-Saliva98/79 SARS-CoV-2 Antigen Test2 refs98/79 SARS-CoV-2 IgG Rapid Test98/79 SARS-CoV-2 Neutralization Antibody Rapid Test98/79 SARS-CoV-2 NPAb and NAb Combo Rapid Test98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test98/79 Strep A Rapid Test (Control Line in Blue)2 refs98/79 Strep A Rapid Test (Control Line in Red) I045-500198/79 Strep A Rapid Test (Control Line in Red) I045-500298/79 Strep A Test Kit YI051-500298/79 Strep B Rapid Test I004-500198/79 Strep B Rapid Test I004-500298/79 Streptococcus pneumoniae Antigen Rapid Test98/79 Streptococcus pneumoniae Test Kit98/79 Syphilis control HSCSYP-L98/79	B IVDR, 98/79	EUDAMED record Report an error
Bitrumed EU representative : VidaQuick Biotech S.L. (Spain)	China	Adenovirus &RSV Combo Test AR-5C298/79 Adenovirus, RSV & Flu A+B Combo Test98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Ag Combo Test98/79 Clostridium difficile GDH & Toxin A &Toxin B Combo Test CD-6C398/79 Clostridium difficile GDH & Toxin A &Toxin B Combo Test CD-6F398/79 65 others Clostridium difficile GDH Rapid Test Cassette ICDG-60298/79 Clostridium difficile GDH Test CDG-6C198/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette ICD-635B98/79 Clostridium difficile Toxin A &Toxin B Combo Test CDT-6C298/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette ICDT-625B98/79 Dengue/Chikungunya/Zika Combo Test DCZ-4C398/79 Dengue/Zika/Chikungunya Combo Test DZC-4C498/79 EBNA IgG Test ENG-4C198/79 EBV VCA & EBNA IgG Combo Test ECN-4C298/79 EBV VCA IgG Test ECG-4C198/79 Flu A Test2 refs98/79 Flu A+B Test2 refs98/79 Flu A/B & H1N1 Combo Test98/79 H1N1 Test98/79 HSV 1/2 IgG Test2 refs98/79 HSV 1/2 IgG/IgM Test4 refs98/79 HSV 1/2 IgM Test2 refs98/79 Influenza A+B Rapid Test Cassette IIN-50298/79 Influenza A+B Rapid Test Dipstick98/79 Legionella pneumophila Rapid Test Cassette98/79 Legionella pneumophila Test98/79 Malaria P.f. Test MAL-4A198/79 Malaria P.f. Test MAL-4C198/79 Malaria P.f./ P.v. /Pan Test MPVF-4C198/79 Malaria P.f./ P.v. Test MPV-4C198/79 Malaria P.f./ Pan Test MPN-4C198/79 Monkeypox Virus Antibody Test MXB-4C198/79 MONO Test MONO-4C198/79 Norovirus, Rotavirus & Adenovirus Test NRA-6C298/79 Norovirus, Rotavirus & Adenovirus Test NRA-6F298/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test NRAA-6C398/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test NRAA-6F498/79 Rotavirus & Adenovirus Test RA-6C198/79 Rotavirus & Adenovirus Test RA-6F198/79 Rotavirus and Adenovirus Combo Rapid Test Cassette IRAC-62598/79 RSV Rapid Test Cassette IRS-50298/79 RSV Test RSV-5C198/79 RSV&Flu A+B Combo Test98/79 S. pneumoniae Antigen Rapid Test Cassette ISP-10298/79 SARS-CoV-2 & Flu A+B Ag Combo Test2 refs98/79 SARS-CoV-2 & M.pneumoniae IgG Combo Test98/79 SARS-CoV-2 & M.pneumoniae IgG/IgM Combo Test98/79 SARS-CoV-2 Ag Test3 refs98/79 SARS-CoV-2 Ag Test (Nasal Swab)98/79 SARS-CoV-2 Ag Test (Oral fluid)2 refs98/79 SARS-CoV-2 IgG Test2 refs98/79 SARS-CoV-2 IgG/IgM Test2 refs98/79 SARS-CoV-2 Neutralization Antibody Test98/79 SARS-CoV-2 S-RBD IgG Antibody Test98/79 SARS-CoV-2/Flu A+B/RSV Ag Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus Ag Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus/M.pneumoniae Ag Combo Test98/79 Strep A Rapid Test Cassette IST-50298/79 Strep A Test STA-5A198/79 Strep A Test STA-5C198/79 Strep A Test STAB-5A198/79 Strep A Test STAB-5C198/79 Strep B Rapid Test Cassette ISB-50298/79 Strep B Test STB-5A198/79 Strep B Test STB-5C198/79 Streptococcus pneumoniae Ag Test98/79 Syphilis Test SYP-3A198/79 Syphilis Test SYP-3C198/79 Syphilis Test SYP-4A198/79 Syphilis Test SYP-4C198/79	– 98/79	info@bitrumed.com.cn EUDAMED record Report an error
Safecare FDA EU representative : Medunion S.L. (Spain) and 4 others	China	"H.pylori Antibodies Rapid Test Kit (Whole Blood/serum/plasma)" HPAb-4011/HPAb-401298/79 Bacterial Vaginosis Multi-Test Kit98/79 Bacterial Vaginosis Multi-Test(Swab)98/79 Cardiac Troponin I Rapid Test Kit(Whole Blood/serum/plasma) CTNI-401298/79 COVID-19 & Influenza A+B Antigen Combo Rapid Test98/79 63 others COVID-19 Antigen FIA Test (Swab)98/79 COVID-19 Antigen Rapid Test Kit (Swab)98/79 COVID-19 IgG/IgM FIA Test (Serum/Plasma)98/79 COVID-19 IgG/IgM FIA Test (Whole blood/Serum/Plasma)98/79 COVID-19/Flu/RSV/ADV/hMPV Antigen Combo Rapid Test98/79 COVID-19/Flu/RSV/ADV/hMPV/HPIV Antigen Combo Rapid Test98/79 COVID-19/Flu/RSV/ADV/MP Antigen Combo Rapid Test(Swab)98/79 COVID-19/FluA&B/RSV/ADV/MP Antigen Combo Rapid Test(Swab)98/79 Dengue IgG/IgM Rapid Test (Serum/Plasma) DEN-302298/79 Dengue IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) DEN-402298/79 Dengue IgG/IgM Rapid Test Kit(Whole Blood/serum/plasma) DEN-302298/79 Dengue IgG/IgM/NS1 Combo Rapid Test (WB/S/P)98/79 Dengue IgG/IgM/NS1 Combo Rapid Test (Whole Blood/Serum/Plasma)98/79 Dengue IgG/IgM/NS1 Combo Rapid Test(Serum/Plasma)98/79 Dengue NS1 Rapid Test (Serum/Plasma)98/79 Dengue NS1 Rapid Test (Whole Blood/Serum/Plasma)98/79 Dengue NS1 Rapid Test Kit(Whole Blood/serum/plasma)98/79 H.pylori Antibodies Rapid Test (Serum/Plasma) HPAb-3011/HPAb-301298/79 H.pylori Antibodies Rapid Test (Whole Blood/Serum/Plasma) HPAb-4011/HPAb-401298/79 H.pylori Antigen FIA Test (Feces)98/79 H.pylori Antigen Rapid Test (Feces) HPAg-5011/HPAg-501298/79 H.pylori Antigen Rapid Test Kit(Feces) HPAg-5011/HPAg-501298/79 Influenza A/B Antigen FIA Test (Swab)98/79 Influenza A/B Antigen Rapid Test（Swab） FLU-602298/79 Kit de Detección Rápida de Antígenos de COVID-19 (Hisopo)-Nasal98/79 Kit de prueba de antígenos de múltiples virus respiratorios ( Hisopo ) (Gripe A+B/ COVID-19)98/79 Malaria P.f. Rapid Test (Whole Blood) MAL-4011a/MAL-4012a98/79 Malaria P.v. Rapid Test (Whole Blood) MAL-4011b/MAL-4012b98/79 Malaria P.f. Rapid Test Kit(Whole Blood) MAL-4011/MAL-4012a98/79 Malaria P.f./P.v. Rapid Test Kit(Whole Blood) MAL-4022a98/79 Malaria P.f./P.v. Rapid Test (Whole Blood) MAL-4022a98/79 Malaria P.f./Pan Rapid Test Kit(Whole Blood) MAL-4022b98/79 Malaria P.f./Pan Rapid Test (Whole Blood) MAL-4022b98/79 Malaria P.v./Pan Rapid Test (Whole Blood) MAL-4022c98/79 Malaria Pan Rapid Test (Whole Blood) MAL-4011c/MAL-4012c98/79 Monkeypox Virus Antigen Rapid Test98/79 Monkeypox Virus Antigen Rapid Test(Serum/Plasma) MON Ag-301298/79 Monkeypox Virus Antigen Rapid Test(Swab) MON Ag-601298/79 Monkeypox Virus Antigen Rapid Test(Whole blood/Serum/Plasma) MON Ag-401298/79 Monkeypox Virus IgG/IgM Rapid Test(Serum/Plasma) MON Ab-302298/79 Monkeypox Virus IgG/IgM Rapid Test(Whole blood/Serum/Plasma) MON Ab-402298/79 Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19)98/79 Multi-Respiratory Virus Antigen Test(Swab) (Influenza A+B/ COVID-19)98/79 Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Kit98/79 Mycoplasma pneumoniae(MP) IgG/IgM Combo Rapid Test(Serum/Plasma)98/79 Mycoplasma pneumoniae(MP) IgG/IgM Combo Rapid Test(Whole Blood/Serum/Plasma)98/79 Prueba rápida combinada de antígenos de COVID-19/Gripe/VSR (Hisopo)98/79 Prueba Rápida Combinada de Antígenos de COVID-19 y Gripe A+B98/79 Respiratory Pathogens Antigen Combo Rapid Test MID-614298/79 Rotavirus Antigen Rapid Test(Feces) ROT-5011/ROT-501298/79 Rotavirus Rapid Test (Feces) ROT-5011/ROT-501298/79 RSV Antigen FIA Test (Swab)98/79 RSV Antigen Rapid Test RSV-6011/ RSV-601298/79 RSV Antigen Rapid Test(Swab) RSV-6011/RSV-601298/79 Strep A Rapid Test (Swab) STA-6011/STA-601298/79 Strep A Rapid Test Kit (swab) STA-6011/STA-601298/79 Strep B Rapid Test (Swab) STB-6011/STB-601298/79 Strep B Rapid Test Kit (swab) STB-6011/STB-601298/79 Syphilis Rapid Test (Serum/Plasma) SYP-3011/SYP-401198/79 Syphilis Rapid Test (Whole Blood/Serum/Plasma) SYP-4011/SYP-401298/79 Syphilis Rapid Test Kit(Whole Blood/serum/plasma)98/79 ViraxClear Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo) COVID-19/Flu A&B/RSV/ADV Antigen Combo Rapid Test98/79 Συνδυαστικό τεστ ταχείας ανίχνευσης αντιγόνου του COVID-19 και της Ινφλουέντζας A+B Για αυτοδοκιμή COVID-19 & Influenza A+B Antigen Combo Rapid Test98/79	– 98/79	EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain)	China	Adenovirus, RSV and Influenza A+B Combo Rapid Test Cassette ARAB-5-L98/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test Cassette ARI-5-E98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 54 others Clostridium difficile GDH Rapid Test Cassette CLO-2-F98/79 Clostridium difficile GDH+Toxin A+Toxin B Combo Rapid Test CGAB-7-F98/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test Cassette CTAB-5-F98/79 Clostridium diffilcile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette98/79 COVID-19 and Influenza A+B Antigen Combo Control98/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test2 refs98/79 COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test98/79 Dengue IgG&IgM/Zika IgG&IgM/Chikungunya IgG/Chikungunya IgM Combo Rapid Test Cassette DZC-5-D98/79 EBV VCA and EBNA IgG Combo Rapid Test Cassette EBCN-5-D98/79 EBV VCA IgG Rapid Test Cassette EBVG-2-D98/79 H1N1 Antigen Rapid Test Cassette98/79 HSV 1/2 IgG/IgM Rapid Test Cassette2 refs98/79 Influenza A Rapid Test Cassette IFA-2-K98/79 Influenza A Rapid Test Dipstick98/79 Influenza A+B Control Q-FLAB-E98/79 Influenza A+B Rapid Test Cassette IFAB-2-K98/79 Influenza A+B Rapid Test Cassette IFLU-2-K98/79 Influenza A+B Rapid Test Dipstick98/79 Influenza A/B+H1N1 Combo Rapid Test Cassette98/79 Legionella pneumophila Rapid Test Cassette98/79 Malaria P.f. /Pan Rapid Test Cassetle98/79 Malaria P.f. Rapid Test Cassette MAF-2-D98/79 Malaria P.f. Rapid Test Dipstick98/79 Malaria P.f./P.v. /Pan Rapid Test Cassette MAFVN-2-D98/79 Malaria P.f./P.v. Rapid Test Cassette MAFV-2-D98/79 Monkeypox Virus Antibody Rapid Test MXB-2-D98/79 Monkeypox Virus Antigen Rapid Test Cassette MXG-2-D98/79 MONO Rapid Test Cassette MONO-2-D98/79 Multiplex Respiratory Antigen Rapid Test RT9-5-E98/79 Norovirus, Rotavirus and Adenovirus Combo Rapid Test Cassette NRA-5-F98/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Cassette NRAA-5-F98/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test NRAA-7-F98/79 Rotavirus and Adenovirus Combo Rapid Test Cassette ROA-2-F98/79 Rotavirus and Adenovirus Rapid Test ROA-7-F98/79 RSV Control Q-RSV-E98/79 RSV Rapid Test Cassette RSV-2-K98/79 RSV&Influenza A+B Combo Rapid Test Cassette RVIF-5-K98/79 RSV/HMPV Combo Rapid Test98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test98/79 SARS-CoV-2 Antibody rapid test98/79 SARS-CoV-2 Antigen Control98/79 SARS-CoV-2 Antigen rapid test4 refs98/79 SARS-CoV-2 neutralizing Antibody rapid test98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Control98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test98/79 Strep A Rapid Test Cassette (Control Line in Red) STA-2-G98/79 Strep A Rapid Test Dipstick (Control Line in Red)98/79 Strep B Rapid Test Cassette STB-2-E98/79 Strep B Rapid Test Dipstick98/79 Syphilis Rapid Test Cassette SYP-2-C98/79 Syphilis Rapid Test Cassette SYP-2-D98/79 Syphilis Rapid Test Dipstick2 refs98/79	– 98/79	info@actest.com.cn EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : Medunion S.L. (Spain) and 1 other	China	303034-0198/79 303034-0598/79 303034-4098/79 303057; 3030582 refs98/79 303059; 303060; 30306198/79 50 others BIOSYNEX 86079398/79 Chlamydia Antigen Rapid Test Kit Cassette ICH-502 LYHER 303021901 LYHER 3030340023 refs LYHER 303034701-01;303034701-05;303034701-20;303034701-25;303034701-403 refs LYHER 3030348013 refs LYHER 3030419013 refs LYHER 303045201-01;303045201-05;303045201-20;303045201-25;303045201-403 refs LYHER ICO-502-01; ICO-502-05; ICO-502-20; ICO-502-25; ICO-502-403 refs LYHER IDE-425-01; IDE-425-05; IDE-425-20; IDE-425-25; IDE-425-403 refs LYHER IDE-A402-01; IDE-A402-05; IDE-A402-20; IDE-A402-25; IDE-A402-403 refs LYHER IDE-B402-01; IDE-B402-05; IDE-B402-20; IDE-B402-25; IDE-B402-403 refs LYHER IFL-5022 refs LYHER IFL-A5022 refs LYHER IMA-402-0198/79 LYHER IMA-402-0298/79 LYHER IMA-402-0598/79 LYHER IMA-402-0798/79 LYHER IMA-402-2098/79 LYHER IMA-402-2598/79 LYHER IMA-402-4098/79 LYHER IMPXVAB-502-0198/79 LYHER IMPXVAB-502-0598/79 LYHER IMPXVAB-502-2098/79 LYHER IMPXVAB-502-2598/79 LYHER IMPXVAB-502-4098/79 LYHER IMPXVAG-502-0198/79 LYHER IMPXVAG-502-0598/79 LYHER IMPXVAG-502-2098/79 LYHER IMPXVAG-502-2598/79 LYHER IMPXVAG-502-4098/79 LYHER IRS-5022 refs LYHER IRS-582-0198/79 LYHER IRS-582-0298/79 LYHER IRS-582-0598/79 LYHER IRS-582-0798/79 LYHER IRS-582-2098/79 LYHER IRS-582-2598/79 LYHER IRS-582-4098/79 LYHER ISA-502-0198/79 LYHER ISA-502-0298/79 LYHER ISA-502-0598/79 LYHER ISA-502-0798/79 LYHER ISA-502-2098/79 LYHER ISA-502-2598/79 LYHER ISA-502-4098/79 LYHER ISY-401-01;ISY-401-05; ISY-401-20; ISY-401-25; ISY-401-403 refs LYHER ISY-402-01; ISY-402-05; ISY-402-20; ISY-402-25; ISY-402-403 refs Malaria Antigen Test Kit98/79 Respiratory Multiple Rapid Test98/79	B, C IVDR, 98/79	office@lyher.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	ACAB04D-BOG48E98/79 AFAB01-AOG48E; AFAB01-AOG96E98/79 AFAB03-AOG48E; AFAB03-AOG96E; AFAB03D-AOG48E; AFAB03D-AOG96E98/79 AFR01-AOG48E; AFR01-AOG96E; AFR01D-AOG48E; AFR01D-AOG96E98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a98/79 49 others Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NA98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NN98/79 COVID-19 & Influenza A/B Rapid Test Cassette (Swab) GCFC-525Sa98/79 COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab) GCCOV(B117)-525a98/79 COVID-19 Ag Rapid Test Cassette (Oral Fluid) GCCOV-702a98/79 COVID-19 Antigen Control Kit GCCOV(Ag)-PN10，GCCOV(Ag)-PN2098/79 COVID-19 IgG/IgM CONTROL Kit GCCOV-PN10，GCCOV-PN2098/79 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402a98/79 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402Ba98/79 COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) GCFC-T502a98/79 Dengue NS1 Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(NS)-402c98/79 Digital COVID-19 Ag Rapid Test (Swab) GCCOV-D503a98/79 Flu A Ag Rapid Test Cassette (Swab) GCFLU(A)-U502a98/79 Influenza A & B Ag Rapid Test Cassette (Swab) GCFLU(A/B)-502a98/79 Influenza A & B Ag Rapid Test Cassette (Swab) GCFLU(A/B)-502a, GCFLU(A/B)-502Ca98/79 Influenza A & B Ag Rapid Test Cassette (Swab) GCFLU(A/B)-502Ca98/79 Influenza A & B Ag Rapid Test Strip (Swab) GCFLU(A/B)-501a98/79 Influenza A (H5) Ag Rapid Test Cassette (Swab) GCFLU(AH5)-502a98/79 Influenza A Ag Rapid Test Strip (Swab) GCFLU(A)-501a98/79 Malaria P.f. Ag Rapid Test Casssette (Whole Blood) GCMAL(pf)-402a98/79 Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pv)-402a98/79 Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pan)-402a98/79 Malaria Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pan)-402a98/79 Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma) GCMAL(pf/pv Ab)-302a98/79 Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma) GCMAL(pf/pv Ab)-402a98/79 Monkeypox Ag Rapid Test Cassette (Swab) GCMKP-502b98/79 Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMKP-402a98/79 Mononucleosis IgG/IgM Rapid Test Cassette (Serum/Plasma) GCMON-325a98/79 Mononucleosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMON-425a98/79 Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMON-402a98/79 Rapid COVID-19 Antigen Test Strip GCCOV-501a98/79 Rapid Influenza A & B Antigen Test GCFLU(A/B)-502a-DRH1,GCFLU(A/B)-502a-DRH2,GCFLU(A/B)-502a-DRH5,GCFLU(A/B)-502a-DRH7,GCFLU(A/B)-502a-DRH203 refs RSV Antigen Rapid Test Cassette (Swab) GCRSV-502a98/79 SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)98/79 SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab) GCCOV(Del)-T502a98/79 SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Whole Blood/Serum/Plasma) GCCOV(NAb)-402b98/79 Smart Rapid COVID-19 & Flu A/B Ag Test Device GCFC-T503a98/79 Smart Rapid COVID-19 Ag Test Device GCCOV-503a98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-501a-DR,GCSTR-501Ca-DR,GCSTR-502a-DR,GCSTR-502Ca-DR3 refs Strep A Rapid Test Cassette (Throat Swab) GCSTR-502a98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502Ca98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502CSa98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501a98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501Ca98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501CSa98/79 Syphilis Ab Rapid Test Cassette (Serum/Plasma) GCSYP-302a98/79 Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCSYP-402a98/79 Syphilis Ab Rapid Test Strip (Serum/Plasma) GCSYP-301a98/79 Syphilis Ab Rapid Test Strip (Whole Blood/Serum/Plasma) GCSYP-401a98/79	B, C IVDR, 98/79	EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others	China	C. difficile GDH FIA GDH-F23F398/79 C. difficile Toxin A/B Rapid Test Format (cassette): A4A93011 A4A930125 A4A930140 A4A93021 A4A930225 A4A930240 COVID 19 Rapid Test98/79 COVID-19 & Influenza A/B & RSV & ADV & HMPV Antigen Combo Test COVID-19 & Influenza A/B & RSV Antigen Combo Rapid Test98/79 46 others COVID-19& Influenza A/B& RSV Antigen Combo Test Format (cassette): A4981011 A49810120 A49810140 A4981021 A49810220 A49810240 Format (pen): A4776011 A47760120 A4776021 A47760220 COVID-19&Influenza A/B Antigen combo Test Format (cassette): A4943011 A49430120 A49430140 A4943021 A49430220 A49430240 Format (pen): A4766011 A47660120 A4766021 A47660220 COVID-19&Influenza A/B&RSV&ADV Antigen combo Test Format (cassette): A4933011 A49330120 A49330140 A4933021 A49330220 A49330240 Format (pen): A4956011 A49560120 A4956021 A49560220 COVID-19&Influenza A/B&RSV&ADV&MP Antigen combo Test Format (cassette): A4923011 A49230120 A49230140 A4923021 A49230220 A49230240 Format (pen): A4D56011 A4D560120 A4D56021 A4D560220 COVID-19&Influenza A/B&RSV&ADV&MP&HMPV Antigen combo Test Format (cassette): A4D73011 A4D730120 A4D730140 A4D73021 A4D730220 A4D730240 COVID-19&Influenza A/B&RSV&ADV&MP&HMPV&HPIV Antigen combo Test Format (cassette): A4D83011 A4D830120 A4D830140 A4D83021 A4D830220 A4D830240 Dengue Rapid Test Den-W23M NS1-W2398/79 Device A40110120 Device A41511125 Device A4291011 Device A4303011 Device A4343011 Device A4347011 Device A4353011 Device A4357011 Device A45910120 Device COV-S23004H198/79 Fastep MI-S33001H598/79 FLU A/B FIA FLU-S23F398/79 FLU A/FLU B/RSV/ADV/MP/COVID-19 Combo Test98/79 H. pylori Antibodies Rapid Test HP-P11, HP-P23, HP-W11, HP-W2398/79 H. pylori Antibodies Rapid Test HP-W2398/79 H. pylori Antibody FIA HP-W23F398/79 H. pylori Antigen FIA HP-F23F398/79 HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)98/79 Influenza A/B & RSV & ADV Antigen Combo Test Influenza A/B & RSV Antigen Combo Test A4C83011 Influenza A/B Rapid Test Device A46071120,A46071220 Influenza A/B Rapid Test FLU-S23M98/79 Influenza A/B&ADV Antigen combo Test Format (cassette): A4D33011 A4D330120 A4D330140 A4D33021 A4D330220 A4D330240 Format (pen): A4D36011 A4D360120 A4D36021 A4D360220 Legionella Antigen Rapid Test Device (Urine) LEG-U2398/79 Malaria P.f Rapid Test Mal pf-W11M, Mal pf-W23M98/79 Malaria P.f/Pan Rapid Test Mal pf/pan-W11M,Mal pf/pan-W23M98/79 Malaria pf/pv Rapid Test Mal pf/pv-W11M, Mal pf/pv-W23M98/79 Mycoplasma Pneumoniae Antigen Rapid Test Device A46710120,A46710220 Rotavirus-Adenovirus-Astrovirus-Norovirus Combo Test A4B630 Rotavirus-Adenovirus-Astrovirus-Norovirus Combo test AT-MI-F4400198/79 Rotavirus-Adenovirus-Norovirus Combo Test Format (cassette): A4A13011 A4A130125 A4A130140 A4A13021 A4A130225 A4A130240 RSV Antigen Nasal test Kit RSV-W3598/79 RSV FIA RSV-S23F398/79 STA FIA STA-S23F398/79 Strep A Rapid Test Device Strip, Device A46310113 refs Strep A Rapid Test STA-S2398/79 Strep B Rapid Test STB-S2398/79 Syphilis FIA SYP-W23F398/79 Syphilis Rapid Test SYP-P11, SYP-P23, SYP-W11, SYP-W2398/79	B, C IVDR, 98/79	Website contact@diareagent.com EUDAMED record Report an error
Vivachek FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	C. difficile Toxin A/B Rapid Test VICT98/79 C. difficile Toxin A/B+GDH Rapid Test VITG98/79 Dengue IgG/IgM and NS1 Combo Rapid Test VIDE98/79 Dengue IgG/IgM and NS1 Combo Rapid Test VIDE-42698/79 Dengue IgG/IgM Rapid Test VIDEb98/79 42 others Dengue IgG/IgM Rapid Test VIDEb-40298/79 Dengue NS1 Ag Rapid Test VIDEg98/79 Dengue NS1 Ag Rapid Test VIDEg-40298/79 H. pylori Ab Rapid Test VIHP2 refs98/79 H. pylori Ag Rapid Test VIHP98/79 H. pylori Ag Rapid Test VIHP-40198/79 H. pylori Antibody Test Kit (FIA) VID8298/79 H. pylori Antigen Test Kit ( FIA) VID8398/79 Influenza A Rapid Test VIFLa98/79 Influenza A+B Rapid Test VIFLab98/79 Legionella Pneumophila Rapid Test VILEG-10198/79 Malaria P.f. Rapid Test VIMPf98/79 Malaria P.f./P.v. Rapid Test VIMPfv98/79 Malaria P.f./P.v. Rapid Test VIMPfv-22698/79 Malaria P.f./P.v./Pan Rapid Test VIMP98/79 Malaria P.f./Pan Rapid Test VIMP98/79 Malaria P.v. Rapid Test VIMPv98/79 Mononucleosis Rapid Test VIMO98/79 Mononucleosis Rapid Test VIMO-40198/79 Multiplex Respiratory Antigen Rapid Test VIRI3 refs98/79 Mycoplasma pneumoniae Ag Rapid Test VIMPg98/79 Mycoplasma pneumoniae IgM Rapid Test VIMPb98/79 Pro SARS-CoV-2 Ag Rapid Test VCD1698/79 Quick MASTER SARS-CoV-2 Ag FIA Test VID442 refs98/79 Quick MASTER Strep A Test Kit (FIA) VID1072 refs98/79 RSV Rapid Test VIRS2 refs98/79 S.pneumoniae Rapid Test VISP98/79 SARS-CoV-2 Ag Rapid Test VCD0598/79 SARS-CoV-2 IgG Rapid Test VCD24-01-01398/79 SARS-CoV-2 S-RBD IgG Ab Rapid Test VCD25-01-01398/79 SARS-CoV-2/Flu A/Flu BAg Rapid Test VLD0198/79 SARS-CoV-2/Influenza A+B Ag Combo Rapid Test VIRI98/79 SARS-CoV-2/Influenza A+B Ag Combo Rapid Test VLD01-03-1398/79 Strep A Rapid Test VIST98/79 Strep A Rapid Test VIST-70198/79 Strep A Test VIST98/79 Strep B Rapid Test VISB98/79 Streptococcus pneumoniae Ag Rapid Test VISP98/79 Syphilis Control Solution (FIA) VIC18898/79 Syphilis Rapid Test VISY98/79 Syphilis Rapid Test VISY-40298/79 Syphilis Test Kit (FIA) VID18898/79	– 98/79	info@vivachek.com EUDAMED record Report an error
nal von minden	Germany	dedicio® Strep A Test3 refs98/79 FUTURLAB® Strep A Test98/79 Hitado Mononucleosis Test98/79 Hitado strep a2 refs98/79 Hitado strep a Test3 refs 41 others Lagaay Malaria Pf/Pan Ag 4 Species Test Malaria Pf/Pan Ag 4 SpeciesTest98/79 meditrol® Strep A Test98/79 NADAL TPHA Microplate Haemagglutination Test98/79 NADAL® C. difficile GDH Ag Test2 refs98/79 NADAL® C. difficile Toxin A/B Test2 refs98/79 NADAL® C. difficile Toxin A/B+GDH Test2 refs98/79 NADAL® Chlamydia plus Test (CE0197) Chlamydia Test (CE0197)98/79 NADAL® Chlamydia Test (CE0197)98/79 NADAL® COVID-19 Ag Test98/79 NADAL® COVID-19 Ag Test CE01979 refs98/79 NADAL® COVID-19 IgG/IgM Test98/79 NADAL® Dengue NS1 Ag+IgG/IgM Test98/79 NADAL® H.pylori Ag Test2 refs98/79 NADAL® H.pylori Ab Test2 refs98/79 NADAL® Influenza A/B Scan Test98/79 NADAL® Influenza A/B Test2 refs98/79 NADAL® Legionella /S. pneumoniae Test98/79 NADAL® Legionella Test2 refs98/79 NADAL® Malaria Pf/Pan Ag 4 Species plus Test3 refs98/79 NADAL® Malaria Pf/Pan Ag 4 Species Test2 refs98/79 NADAL® Mononucleosis Test3 refs98/79 NADAL® Mpox Ag Test98/79 NADAL® Norovirus GI/GII+Rota-Adenovirus Test98/79 NADAL® Rota-Adenovirus Test98/79 NADAL® RPR Carbon Test98/79 NADAL® RSV Test98/79 NADAL® S. pneumoniae Test2 refs98/79 NADAL® Strep A Plus Test2 refs98/79 NADAL® Strep A Scan Test98/79 NADAL® Strep A Test8 refs NADAL® Strep B98/79 NADAL® Strep B Test98/79 NADAL® Syphilis Test2 refs98/79 NADAL® VDRL Test98/79 NEO CITOSTREP® Strep A Test98/79 S-MedPro H.pylori Ab Test98/79 S-MedPro H.pylori Ag Test98/79 S-MedPro Strep A Test98/79 S-MedPro Strep B Test98/79 Secu® Strep A Test6 refs98/79 StrepA PreMax® Test2 refs98/79	B IVDR, 98/79	Website info@nal-vonminden.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	3'Ü 1 ARADA SOLUNUM HIZLI TEST KİTİ RESPIRATORY 3 IN 1 RAPID TEST KIT 4'Ü 1 ARADA SOLUNUM HIZLI TEST KİTİ RESPIRATORY 4 IN 1 RAPID TEST KIT 5'İ 1 ARADA SOLUNUM HIZLI TEST KİTİ RESPIRATORY 5 IN 1 RAPID TEST KIT Beyaz Akciğer Sendromu Mini Panel Hızlı Test Kiti C. DIFFICILE TOXIN A/TOXIN B/GDH RAPID TEST KIT VISD075 39 others C. DIFFICILE/ GDH HIZLI TEST KİTİ CHLAMYDIA RAPID TEST KIT VISD029 Clostridium Difficile Toxin A+B Rapid Test VISD125 CMV AB HIZLI TESTİ COVID 19 HIZLI ANTİJEN TEST KİTİ COVID 19 RAPID ANTIGEN TEST KIT COVID 19 RAPID POC TEST KIT COVID-19 A/B- RSV- ADENO ÇOKLU HIZLI TEST KİTİ COVID-INF A/B- RSV MULTI RAPID TEST KIT COVID-INF A/B- RSV- ADENO- HMPV MULTI RAPID TEST KIT COVID-INFLUENZA A/B RAPID TEST KIT2 refs DENGUE Ag RAPID TEST KIT VISD035 DENGUE IgG/IgM RAPID TEST KIT VISD025 DENGUE NS1 & IgG-IgM RAPID TEST DENGUE NS1 HIZLI TEST KİTİ DENGUE NS1 RAPID TEST KIT FLU A/B-RSV RAPID TEST KIT H.PYLORI AB RAPID TEST VISD013 H.PYLORI AG RAPID TEST VISD012 INFLUENZA A/B RAPID TEST KIT VISD007 INFLUENZA A/B RSV RAPID TEST KIT VISD073 İNFLUENZA A-B/RSV/ADENO HIZLI TEST KİTİ MALARYA Pf/Pv/Pan HIZLI TEST KİTİ MONKEYPOX AB RAPID TEST KIT VISD051 Monkeypox Detection Test Kit VISMPX001 MONO HIZLI TEST KİTİ MYCOPLASMA PNEUMONIAE AB HIZLI TEST KİTİ SARS-CoV-2 NEUTRALIZING ANTIBODY RAPID TEST KIT NOROVIRUS-ROTAVIRUS AG RAPID TEST KIT VISD134 ROTA-ADENO-ASTRO-NOROVİRÜS ÇOKLU HIZLI TEST KİTİ ROTA-ADENO-NOROVIRUS RAPID TEST KIT ROTAVIRUS-ADENOVIRUS AG RAPID TEST VISD009 RSV HIZLI TEST KİTİ SOLUNUM YOLU PATOJENLERİ TARAMA 24 PARÇALI KİTİ RESPIRATORY PATHOGENS SCREENING 24P KIT STREP A RAPID TEST KIT VISD024 Streptococcus Pneumoniae Hızlı Test Kiti STREPTOCOCCUS PNEUMONIAE-LEGIONELLA PNEUMOPHILA HIZLI TEST KİTİ Sıtma Pf Hızlı Test Kiti TORCH IgG-IgM RAPID TEST KIT TOXIN A/B RAPID TEST KIT VISD034 VZV Detection Kit VSNMP013 White Lung Syndrome Middle Panel Rapid Test Kit VISD079	B, C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Ameritech Diagnostic Reagent (Jiaxing) EU representative : AR Experts B.V. (Netherlands) and 1 other	China	Exacto-85879598/79 PreventID Strep A R34-11298/79 PreventID Strep B R66-11298/79 R10-11098/79 R10-11698/79 38 others R102-11098/79 R102-11298/79 R102-11498/79 R108-11098/79 R108-11298/79 R109-11298/79 R11-11098/79 R11-11698/79 R13-11098/79 R13-11698/79 R16-11098/79 R16-11298/79 R18-11098/79 R18-11298/79 R18-11698/79 R19-11098/79 R19-11298/79 R200-11298/79 R310-11298/79 R330-11298/79 R34-11098/79 R34-11298/79 R66-11098/79 R66-1122 refs98/79 R70-11098/79 R70-11298/79 R70-11698/79 R84-11098/79 R84-11298/79 R85-11098/79 R85-11298/79 R89-11098/79 R89-11298/79 R90-11298/79 R92-11098/79 R92-11298/79 R92-11698/79 R98-11298/79	– 98/79	EUDAMED record Report an error
Biotical	Spain	biotical Adenovirus Positive control (1u) / 1 control positivo Adenovirus (sin test rápido)98/79 biotical Adenovirus Positive control (30u) / 30 controles positivos Adenovirus (sin test rápido)98/79 biotical Astrovirus Positive control (1u) / 1 control positivo Astrovirus (sin test rápido)98/79 biotical C. difficile GDH Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile GDH +1 C. Negativo universal)98/79 biotical C. difficile GDH Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile GDH)98/79 37 others biotical C. difficile GDH Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79 biotical C. difficile GDH Positive control (1u) / 1 control positivo C. difficile GDH (sin test rápido)98/79 biotical C. difficile GDH Positive control (30u)98/79 biotical C. difficile Toxin A Positive control (1u) / 1 control positivo C. difficile Toxins A (sin test rápido)98/79 biotical C. difficile Toxin A Positive control (30u) / 30 controles positivos C. difficile Toxins A (sin test rápido)98/79 biotical C. difficile Toxin B Positive control (1u)98/79 biotical C. difficile Toxin B Positive control (30u) / 30 controles positivos C. difficile Toxins B (sin test rápido)98/79 biotical C. difficile Toxins A + B Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile Toxins A + B +1 C. Negativo universal)98/79 biotical C. difficile Toxins A + B Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo C. difficile Toxins A + B)98/79 biotical C. difficile Toxins A + B Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79 biotical Campylobacter Positive control (1u) / 1 control positivo Campylobacter (sin test rápido)98/79 biotical Campylobacter Positive control (30u) / 30 controles positivos Campylobacter (sin test rápido)98/79 biotical Crypto Positive control (30u) / 30 controles positivos Crypto (sin test rápido)98/79 biotical E. Coli Positive control (1u) / 1 control positivo E. Coli O157:H7 (sin test rápido)98/79 biotical E. Coli Positive control (30u) / 30 controles positivos E. Coli O157:H7 (sin test rápido)98/79 biotical Enterovirus Positive Control (1u) / 1 control positivo Enterovirus (sin test rápido)98/79 biotical Enterovirus Positive Control (30u) / 30 controles positivos Enterovirus (sin test rápido)98/79 biotical Giardia Positive control (1u) / 1 control positivo Giardia (sin test rápido)98/79 biotical Giardia Positive control (30u)98/79 biotical H. pylori Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo H. pylori +1 C. Negativo universal)98/79 biotical H. pylori Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo H. pylori)98/79 biotical H. pylori Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79 biotical H. pylori Positive control (1u) / 1 control positivo H. pylori (sin test rápido)98/79 biotical H. pylori Positive control (30u) / 30 controles positivos H. pylori (sin test rápido)98/79 biotical Norovirus Gen I Positive control (30u) / 30 controles positivos Norovirus Gen I (sin test rápido)98/79 biotical Norovirus Gen II Positive control (1u) / 1 control positivo Norovirus Gen II (sin test rápido)98/79 biotical Norovirus Gen II Positive control (30u) / kit de 30 unidades de hisopo de control negativo universal98/79 biotical Rotavirus Positive control (1u) / 1 unidad de hisopo de control positivo Rotavirus.98/79 biotical Rotavirus Positive control (30u) / 30 controles positivos Rotavirus (sin test rápido)98/79 biotical S. paratyphi Positive control (1u) / 1 unidad de hisopo de control positivo Salmonella paratyphi.98/79 biotical S. paratyphi Positive control (30u) / 30 controles positivos Salmonella paratyphi (sin test rápido)98/79 biotical Salmonella Positive control (1u) / 1 control positivo Salmonella (sin test rápido)98/79 biotical Salmonella Positive control (30u) / 30 controles positivos Salmonella (sin test rápido)98/79 biotical Y. enterocolitica O:3 Positive control (1u) / 1 control positivo Yersinia enterocolitica O:3 (sin test rápido)98/79 biotical Y. enterocolitica O:3 Positive control (30u) / 30 controles positivos Yersinia enterocolitica O:3 (sin test rápido)98/79 biotical Y. enterocolitica O:9 Positive control (1u) / 1 control positivo Yersinia enterocolitica O:9 (sin test rápido)98/79 biotical Y. enterocolitica O:9 Positive control (30u) / 30 controles positivos Yersinia enterocolitica O:9 (sin test rápido)98/79	– 98/79	Website EUDAMED record Report an error
Medotexbio EU representative : HUMISS TRADING S. L. (Spain) and 1 other	China	10-in-1 Respiratory Antigen Combo Rapid Test RVC-5105a-25M 12-in-1 Respiratory Antigen Combo Rapid Test98/79 5-in-1 Respiratory Antigen Combo Rapid Test 6-in-1 Respiratory Antigen Combo Rapid Test98/79 8-in-1 Respiratory Antigen Combo Rapid Test RVC-585b98/79 35 others 8-in-1 Respiratory Antigen Combo Rapid Test RVC-585b-25M Dengue (DENV) IgG/IgM and NS1 Combo Rapid Test Dengue (DENV) NS1 Ag Rapid Test Dengue IgG/IgM and NS1 Combo Rapid Test DENC-435a98/79 Dengue IgG/IgM Rapid Test DEN-422a98/79 Dengue IgG/IgM Rapid Test DEN-422a-25M Dengue NS1 Ag Rapid Test DEN-402b98/79 Flu A&B/SARS-CoV-2 Antigen Combo Test RVC-532b2 refs Flu A&B/SARS-CoV-2/RSV Antigen Combo Test Flu A&B/SARS-CoV-2/RSV/ADV Antigen Combo Test Flu A&B/SARS-CoV-2/RSV/ADV Antigen Combo Test RVC-555b98/79 Flu A&B/SARS-CoV-2/RSV/ADV/hPIV Antigen Combo Rapid Test98/79 Flu A&B/SARS-CoV-2/RSV/ADV/MP Antigen Combo Rapid Test98/79 Flu A&B/SARS-CoV-2/RSV/hMPV Antigen Combo Test98/79 H. pylori Antigen Rapid Test HP-602a98/79 H. pylori Antibody Rapid Test HP-402b98/79 Influenza A/B Antigen Rapid Test FLU-522b2 refs Malaria P.f. Rapid Test MAL-402b Malaria P.f./P.v. Rapid Test MALV-422b Malaria P.f./Pan Rapid Test MALN-422b MALV-422b98/79 Medotex H. pylori Antigen Rapid Test HP-602a Medotex H. pylori Antibody Rapid Test HP-402b Medotex SARS-CoV-2 Antigen Rapid Test 40 Tests98/79 Norovirus/Rotavirus/Adenovirus Antigen Combo Rapid Test GIC-635a98/79 Respiratory Multiple Antigen Combo Test RVC-5X598/79 Respiratory Syncytial Virus (RSV) Antigen Rapid Test RSV-502b Rotavirus/Adenovirus Combo Rapid Test RAC-622a98/79 RSV Antigen Rapid Test RSV-502b98/79 RVC-5105a98/79 RVC-535b RVC-585c98/79 SARS-CoV-2 Antigen Rapid Test Syphilis Rapid Test SYP-401a Syphilis Rapid Test SYP-402b98/79	B, C IVDR, 98/79	Website EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other	China	Cassette IMAL-C5398/79 Cassette IRSVA-C8198/79 Ferrarihub98/79 RightSign8 refs RightSign Home+ 33 others Rightsign ICBAD-MC8398/79 Rightsign ICFGN-MC8398/79 Rightsign ICFR-MC8498/79 Rightsign ICFRA-MC8598/79 Rightsign ICFRAM-MC8698/79 Rightsign ICFRAN-MC8598/79 Rightsign ICOVN-C8198/79 Rightsign ICOVN-C81H98/79 Rightsign IFLU-C8298/79 Rightsign IFLU-S8298/79 RightSign IHBSG-C3198/79 RightSign IHCV-C3198/79 RightSign IHIV-C4298/79 Rightsign IHPB-S4198/79 Rightsign IHPC-MC3298/79 Rightsign ILP-C1198/79 Rightsign IMAL-C5398/79 Rightsign IMON-C4198/79 Rightsign IMPF-C5198/79 Rightsign IMPF-C51S98/79 Rightsign IMPN-C5298/79 Rightsign IMPN-C52S98/79 Rightsign IMPV-C5298/79 Rightsign IMPV-C52S98/79 Rightsign INCP-C8198/79 Rightsign INGM-MC4298/79 Rightsign IRCF-MC8498/79 Rightsign IRCF-MC84S98/79 Rightsign IRCFN-MC8498/79 Rightsign IRSV-C8198/79 Rightsign IRSVA-C8198/79 Rightsign MIDEG-LC4198/79 Rightsign MIDEN-LC4298/79	B, C IVDR, 98/79	info@biotests.com.cn EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Dengue IgG/IgM Combo Test (FIA)98/79 Dengue NS1 Antigen Test (FIA)98/79 Influenza A + B Antigen Test (FIA)98/79 Rapid Dengue IgG/IgM Combo Test Card 1N04C298/79 Rapid Dengue NS1 Antigen and IgG/IgM Duo Panel Test Card 1N24C298/79 30 others Rapid Dengue NS1 Antigen Test Card 1N23C298/79 Rapid Flu A+B/RSV Antigen Test Card98/79 Rapid Flu A+B/RSV/ADV Antigen Test Card98/79 Rapid H.Pylori Antibody Test Card 1O02C298/79 Rapid H.Pylori Antigen Test Card (3mm) 1O03C4298/79 Rapid H.Pylori Antigen Test Card 1O03C498/79 Rapid Influenza A Antigen Test Card 1N17C598/79 Rapid Influenza A+B Antigen Test Card 1N18C598/79 Rapid Legionella Urinary Antigen Test Card 1O05C398/79 Rapid Malaria pan Antigen Test Card 1Q05C298/79 Rapid Malaria pf Antigen Test Card 1Q06C298/79 Rapid Malaria pf/pan Antigen Test Card 1Q10C298/79 Rapid Malaria pf/pv Antigen Test Card 1Q07C298/79 Rapid Respiratory Syncytial Virus Antigen Test Card 1N26C598/79 Rapid SARS-CoV-2 Antigen Test Card3 refs Rapid SARS-CoV-2 Antigen Test Card 1N40C5-2598/79 Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card 1N45C598/79 Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card 1N45C5-198/79 Rapid SARS-CoV-2/Flu A+B/RSV/ADV Antigen Test Card 1N44C598/79 Rapid SARS-CoV-2/Flu A+B/RSV/ADV Antigen Test Card 1N44C5-198/79 Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card 1N41C5-1S-CE3 refs Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card 1N41C5-2598/79 Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card 1N41C5-2798/79 Rapid Strep A Test Card 1O08C598/79 Rapid Strep A Test Card 1O08C5-198/79 Rapid Syphilis Antibody Test Card 1N02C298/79 Rapid Syphilis Antibody Test Strip 1N02S298/79 Respiratory Syncytial Virus Antigen Test (FIA)98/79 SARS-CoV-2 Antigen Test (FIA)98/79 SARS-CoV-2 Neutralizing Antibody Test Card 1N42C298/79	C IVDR, 98/79	Website EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany) and 1 other	China	Candida albicans / Trichomonas vaginalis / Gardnerella vaginalis Triplex Rapid Test Kit98/79 COVID-19&Flu A/B&RSV&Adenovirus Antigen Combo Rapid Test Cassette(Colloidal Gold ) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 COVID-19&Flu A/B&RSV&Adenovirus&MP&HMPV Antigen Combo Rapid Test Cassette(Colloidal Gold ) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 COVID-19&Flu A/B&RSV&Adenovirus&MPAntigen Combo Rapid TestCassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Dengue IgG/IgM/NS1 Rapid Test Kit98/79 30 others Dengue NS1 Detection Kit (Immunofluorescence Chromatography)98/79 Dengue Virus IgG/IgM/NS1 & Chikungunya Virus IgM/IgG Combo Rapid Test Kit98/79 Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) Antigen Combo Rapid Test Kit98/79 Enterovirus 71 (EV71) IgM/IgG Antibody and Coxsackievirus A16 (CA16) IgM/IgG Antibody Combo Rapid Test Kit98/79 Group A Rotavirus & Adenovirus & Norovirus Ag Detection Kit (Immunofluorescence Chromatography)98/79 Group A Rotavirus / Adenovirus / Norovirus Antigen Triplex Rapid Test Kit98/79 Group B Streptococcus Rapid Test Kit98/79 H.Pylori Ag Rapid Test Kit GKPD12998/79 Influenza A/B & RSV & Adenovirus & hMPV & PIV & M. pneumoniae Ag Combo Rapid Test Kit98/79 Influenza A/B Ag Detection Kit (Immunofluorescence Chromatography)98/79 Influenza A/B, SARS-CoV-2, RSV, Adenovirus, Measles Virus, Mumps Virus and HPIV Antigen Combo Rapid Test Kit98/79 Legionella pneumophila Ag Rapid Test Kit98/79 Malaria P.f/P.v Ag Rapid Test Kit GKPD11498/79 MERS-CoV Antigen Rapid Test Kit98/79 Mpox Virus Ag Rapid Test Kit GKPD12398/79 Mpox Virus IgG/IgM Ab Rapid Test Kit GKPD12498/79 Plasmodium falciparum and Pan-plasmodium Antigen Detection Kit (Immunofluorescence Chromatography)98/79 Plasmodium falciparum and Plasmodium vivax Antigen Detection Kit (Immunofluorescence Chromatography)98/79 Respiratory Syncytial Virus (RSV) IgM Ab Rapid Test Kit GKPD10298/79 Rotavirus / Adenovirus / Norovirus (GI/GII) Ag Combo Rapid Test Kit98/79 RSV & ADV Ag Detection Kit (Immunofluorescence Chromatography)98/79 RSV Ag Detection Kit (Immunofluorescence Chromatography)98/79 RSV Antigen Rapid Test Cassette (ColloidalGold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 SARS-CoV-2 Ag Detection Kit (Immunofluorescence Chromatography)98/79 SARS-CoV-2 & Influenza A/B Ag Detection Kit (Immunofluorescence Chromatography)98/79 SARS-CoV-2 / Flu A / Flu B/ ADV Ag Combo Rapid Test Kit98/79 SARS-CoV-2, Influenza A/B, RSV, Adenovirus, M. pneumoniae, hMPV, Rhinovirus, hPIV (1/2/3) and B. pertussis Antigen Combo Rapid Test Kit98/79 Streptococcus pneumoniae Ag Rapid Test Kit98/79 Toxoplasma gondii IgG/IgM, CMV IgG/IgM and Rubella Virus IgG Antibody Combo Rapid Test Kit98/79 Zika Virus IgG/IgM Antibody and Yellow Fever Virus IgG/IgM Antibody Combo Rapid Test Kit98/79	– 98/79	office@guoke-medical.com EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	C. difficile Toxin A/B Rapid Test GICD98/79 Dengue IgG/IgM and NS1 Combo Rapid Test GIDEN98/79 Dengue IgG/IgM and NS1 Combo Test GIDEN98/79 Dengue IgG/IgM Rapid Test GIDENb98/79 Dengue NS1 Ag Rapid Test GIDENg98/79 28 others H. pylori Ab Rapid Test GIHPb98/79 H. pylori Ab Test GIHPb98/79 H. pylori Ag Rapid Test GIHPg98/79 H. pylori Ag Test GIHPg98/79 Influenza A Rapid Test GIFLUA98/79 Influenza A+B Rapid Test GIFLU98/79 Legionella Pneumophila Rapid Test GILeg98/79 Legionella Rapid Test GILeg98/79 Malaria P.f. Rapid Test GIMALf98/79 Malaria P.f./P.v. Rapid Test GIMALfv98/79 Malaria P.f./P.v./Pan Rapid Test GIMP98/79 Malaria P.f./Pan Rapid Test GIMALfa98/79 Malaria Pf/Pan Ag 4 Species Rapid Test GIMAL498/79 MONO Rapid Test GIMONO98/79 Mononucleosis Rapid Test GIMONO98/79 Mononucleosis Test GIMONO98/79 Rota/Adeno Ag Rapid Test GIRA98/79 RSV Rapid Test GIRSV98/79 S.pneumoniae Rapid Test GISPNE98/79 SARS-CoV-2 Ag Rapid Test GISARSg98/79 SARS-CoV-2 Ag Saliva Rapid Test GISARSg98/79 SARS-CoV-2 IgM/IgG Rapid Test GISARSgm98/79 Strep A plus Rapid Test GIST98/79 Strep A Rapid Test GIST98/79 Strep A Rapid Test GISTA-702H3 refs Strep A Rapid Test(Control Line in Red) GIST98/79 Strep B Rapid Test GISTB98/79 Syphilis Rapid Test GISY98/79	C IVDR, 98/79	info@vivachek.com EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit SC20301W-1T98/79 Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit SC20301W-20T98/79 Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit SC20301W-25T98/79 Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit SC20301W-50T98/79 Dengue NS1 Ag Rapid Test Kit SC20101W-1T98/79 26 others Dengue NS1 Ag Rapid Test Kit SC20101W-20T98/79 Dengue NS1 Ag Rapid Test Kit SC20101W-25T98/79 Dengue NS1 Ag Rapid Test Kit SC20101W-50T98/79 Influenza A&B Rapid Test Kit SC10101W-1T98/79 Influenza A&B Rapid Test Kit SC10101W-20T98/79 Influenza A&B Rapid Test Kit SC10101W-25T98/79 Influenza A&B Rapid Test Kit SC10101W-50T98/79 Malaria Pf (HRP2) Ag Rapid Test Kit3 refs Malaria Pf (HRP2) Ag Rapid Test Kit SC20102W-1T98/79 Malaria Pf (HRP2) Ag Rapid Test Kit SC20102W-20T98/79 Malaria Pf (HRP2) Ag Rapid Test Kit SC20102W-25T98/79 Malaria Pf (HRP2) Ag Rapid Test Kit SC20102W-50T98/79 Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit SC20204W-1T98/79 Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit SC20204W-20T98/79 Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit SC20204W-25T98/79 Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit SC20204W-50T98/79 Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit3 refs Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit SC20202W-1T98/79 Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit SC20202W-20T98/79 Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit SC20202W-25T98/79 Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit SC20202W-50T98/79 Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit3 refs Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit SC20203W-1T98/79 Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit SC20203W-20T98/79 Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit SC20203W-25T98/79 Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit SC20203W-50T98/79	C IVDR, 98/79	EUDAMED record Report an error
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	C.difficile GDH + Toxin A/B Combo Rapid Test P240898/79 C.difficile GDH Rapid Test P240998/79 C.difficile Toxin A/B Rapid Test P241098/79 Candida Albicans/Gardnerella Vaginalis/Trichomonas Vaginalis Ag Rapid Test P203298/79 COVID-19 Ag Rapid Test P200498/79 25 others COVID-19 IgG+IgM Rapid Test P200298/79 COVID-19/Flu A+B Ag Rapid Test P2007C01, P2007C02, P2007C05, P2007C203 refs COVID-19/Flu A+B/RSV/hMPV Ag Rapid Test P209798/79 COVID-19/Flu A+B/RSV/Radv/M.p Ag Rapid Test P209698/79 COVID-19/FluA+B/RSV/Radv/hMPV/M.p Ag Rapid Test P208598/79 COVID-19/FluA+B/RSV/Radv/hMPV/M.p/PIV Ag Rapid Test P208898/79 COVID-19/FluA+B/RSV/Radv/hMPV/PIV/hRV Ag Rapid Test P208798/79 COVID-19/RSV/Flu A+B Ag Rapid Test P2081C01, P2081C02, P2081C05, P2081C20.3 refs COVID-19/RSV/Radv/Flu A/B Ag Rapid Test P203998/79 COVID-19/RSV/Radv/hMPV/Flu A+B Ag Rapid Test P208498/79 COVID-19/RSV/Radv/M.P/hMPV/hRV/Flu A+B Ag Rapid Test P208698/79 COVID19/FluA+B/RSV+Radv/hMPV+hRV/PIV/M.p Ag Rapid Test P208998/79 Dengue Virus Ab Rapid Test P204298/79 DIAGOTEC Strep A Rapid Test3 refs EuroGen Flu A+B Ag Rapid Test3 refs Group B Streptococcus (GBS) Ag Rapid Test P202798/79 H. pylori (HP) Ag Rapid Test P202098/79 H.pylori Ab (HP Ab) Rapid Test P202198/79 Malaria P.f/P.v Antigen Rapid Test P204098/79 Malaria Pf/Pan Rapid Test P204198/79 Respiratory Syncytial Virus (RSV) Rapid Test P200898/79 RSV/Radv/Flu A+B Antigen Rapid Test P209098/79 Sinocare Strep A FIA KIT98/79 Strep A/COVID-19 Antigen Rapid Test P230398/79 Strep A/COVID-19/Flu A+B Ag Rapid Test P230498/79	C IVDR, 98/79	Website info@gensurebio.com EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany)	China	Accu-Tell® Clostridium difficile GDH Cassette (Feces)98/79 Accu-Tell® Clostridium difficile GDH +Toxin A+ Toxin B Combo Cassette (Feces)98/79 Accu-Tell® Clostridium difficile Toxin A+ Toxin B Combo Cassette (Feces)98/79 Accu-Tell® Dengue IgG/IgM Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Dengue IgG/IgM/NS1 Combo Cassette (Serum/Plasma)98/79 24 others Accu-Tell® Dengue IgG/IgM/NS1 Combo Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Dengue NS1 Antigen Cassette (Serum/Plasma)98/79 Accu-Tell® Dengue NS1 Antigen Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® H. pylori Antigen Cassette (Feces)98/79 Accu-Tell® H. pylori IgG Cassette(Serum/Plasma)98/79 Accu-Tell® H. pylori IgG Strip (Whole Blood/Serum/Plasma)98/79 Accu-Tell® H. pylori IgG/IgM/IgA Cassette(Whole Blood/Serum/Plasma)98/79 Accu-Tell® H. pylori IgG/IgM/IgA Strip （Whole Blood/Serum/Plasma)98/79 Accu-Tell® Influenza A+B Cassette (Swab/Nasal Aspirate)98/79 Accu-Tell® Influenza A+B Strip (Swab/ Nasal Aspirate)98/79 Accu-Tell® Legionella Pneumophila Antigen Cassette (Urine)98/79 Accu-Tell® Malaria P.f. Cassette(Whole Blood)98/79 Accu-Tell® Malaria P.f./P.v. Cassette(Whole Blood)98/79 Accu-Tell® RSV Antigen Cassette (Swab)98/79 Accu-Tell® Strep A Cassette (Throat Swab)98/79 Accu-tell® Strep A Strip (Throat Swab)98/79 Accu-Tell® Syphilis Cassette (Serum/Plasma)98/79 Accu-Tell® Syphilis Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Syphilis Strip (Serum/Plasma)98/79 Accu-Tell® Syphilis Strip (Whole Blood/Serum/Plasma)98/79 Accu-Tell®H. pylori IgG Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell®Malaria p.f./p.v./pan Cassette(Whole Blood)98/79 Accu-Tell®Malaria P.f./Pan Cassette(Whole Blood)98/79 Accu-Tell®Malaria P.f./Pan Strip(Whole Blood)98/79	– 98/79	sales@accubiotech.com EUDAMED record Report an error
Biosynex EU representative : BIOSYNEX (France)	France, Switzerland	BIOSYNEX C. difficile GDH BIOSYNEX COMBO ADENO/ROTA BSS98/79 BIOSYNEX COMBO COVID-FLU BSS98/79 BIOSYNEX COVID-19 Ag BSS98/79 BIOSYNEX DENGUE Ab BSS98/79 20 others BIOSYNEX DENGUE Ag BSS98/79 BIOSYNEX DENGUE COMBO BSS98/79 BIOSYNEX Legionella pneumophila BSS98/79 BIOSYNEX Legionella pneumophila BSX98/79 BIOSYNEX RSVTOP BSS98/79 BIOSYNEX S.pneumoniae98/79 BIOSYNEX S.pneumoniae BSX98/79 BIOSYNEX Strep A98/79 BIOSYNEX Strep A BSX98/79 CHLAMYTOP98/79 H. Pylori positive control98/79 IMMUNOQUICK NoRotAdeno98/79 INFLUENZATOP BSS98/79 Norovirus GI Positive Control98/79 NOROVIRUS GII positive Control98/79 Positive control swab Adenovirus & Rotavirus SW401998/79 Positive control swab COVID-19 Ag98/79 PYLORITOP Ab BSS98/79 PYLORITOP AG98/79 SYPHILITOP98/79 (no longer marketed)	B IVDR, 98/79	Website reglementaire@biosynex.com EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain)	China	Dengue IgM/IgG Antibody Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79 Dengue IgM/IgG Antibody Rapid Quantitative Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79 Dengue IgM/IgG Antibody Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 Dengue IgM/IgG/NS1 Combo Rapid Test Kit (Lateral Chromatography) 1 Tests/Kit98/79 Dengue IgM/IgG/NS1 Combo Rapid Test Kit (Lateral Chromatography) 25 Tests/Kit98/79 19 others Dengue IgM/IgG/NS1 Combo Rapid Test Kit (Lateral Chromatography) 5 Tests/Kit98/79 Dengue NS1 Antigen Rapid Quantitative Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79 Dengue NS1 Antigen Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 Dengue NS1 Antigen Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79 Influenza A&B Antigen Rapid Test Kit (Immunochromatographic Assay) 1 Test/Kit98/79 Influenza A&B Antigen Rapid Test Kit (Immunochromatographic Assay) 25 Tests/Kit98/79 Influenza A&B Antigen Rapid Test Kit (Immunochromatographic Assay) 5 Tests/Kit98/79 RSV Antigen Rapid Test Kit(Lateral Chromatography) 1 Test/Kit98/79 RSV Antigen Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 RSV Antigen Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV & MP Antigen Combo Rapid Test Kit(Lateral Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV & MP Antigen Combo Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV & MP Antigen Combo Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79 SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) 25 Tests/Kit98/79 SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Aichek FDA EU representative : Medunion S.L. (Spain) and 1 other	China	COVID-19 Antigen Rapid Test98/79 COVID-19 IgG/IgM Rapid Test98/79 COVID-19&Influenza A+B Antigen Rapid Test98/79 COVID-19/ InfluenzaA+B/RSV Antigen Combo Rapid Test COVID-19/ Influenza A+B/RSV Antigen Combo Rapid Test98/79 COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 16 others COVID-19/Influenza A+B/RSV/Adenovirus/MP Antigen Combo Rapid Test98/79 Dengue IgG/IgM Rapid Test DEAB-D02a98/79 Dengue IgG/IgM/NS1 Combo Rapid Test98/79 Dengue NS1 Rapid Test98/79 H. Pylori Antibody Rapid Test HP-D02a, HP-D01a98/79 H. Pylori Antigen Rapid Test HP-F02a98/79 Influenza A+B Antigen Rapid Test FLU-B22b98/79 Malaria P.f. Antigen Rapid Test MAL-D02a98/79 Malaria P.f./P.an. Rapid Test MAL-D22a98/79 Malaria P.f./P.v. Rapid Test MAL-D22b98/79 Respiratory Syncytial Virus (RSV) Antigen Rapid Test RSV-B02b98/79 Rotavirus/Adenovirus Antigen Combo Rapid Test RAV-F22a98/79 Salmonella typhi & Salmonellaparatyphi Antigen Combo Rapid Test98/79 Strep A Antigen Rapid Test STA-B02b98/79 Strep B Antigen Rapid Test STB-K02a98/79 Syphilis Antibody Rapid Test SYP-D02a, SYP-D01a98/79	– 98/79	ra.rep@aichek.com EUDAMED record Report an error
Orasure FDA EU representative : QbD RepS BV (Belgium)	United States	OraQuick HCV Rapid Antibody Test 1001-027098/79 OraQuick HCV Rapid Antibody Test 1001-027498/79 OraQuick HCV Rapid Antibody Test 3001-214198/79 OraQuick HIV Self-Test 1001-060098/79 OraQuick HIV Self-Test 1001-0600U98/79 19 others OraQuick HIV Self-Test 1001-060198/79 OraQuick HIV Self-Test 1001-0601U98/79 OraQuick HIV Self-Test 1001-060298/79 OraQuick HIV Self-Test 1001-0602U98/79 OraQuick HIV Self-Test 1001-060398/79 OraQuick HIV Self-Test 1001-0603U98/79 OraQuick HIV Self-Test 1001-062798/79 OraQuick HIV Self-Test 1001-0627U98/79 OraQuick HIV Self-Test 1001-062898/79 OraQuick HIV Self-Test 1001-0628U98/79 OraQuick HIV Self-Test 1001-062998/79 OraQuick HIV Self-Test 1001-0629U98/79 OraQuick HIV Self-Test 1001-063098/79 OraQuick HIV Self-Test 1001-0630U98/79 OraQuick® HCV Rapid Antibody Test Kit Controls 1001-027898/79 OraQuick HCV Rapid Antibody Test 1001-037098/79 (no longer marketed) OraQuick HCV Rapid Antibody Test 1001-037198/79 (no longer marketed) OraQuick HIV Self-Test 1001-070698/79 (no longer marketed) OraQuick HIV Self-Test 1001-0706U98/79 (no longer marketed)	– 98/79	Website customercare@orasure.com EUDAMED record Report an error
InTec PRODUCTS EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	69361558COVID19-AG-BE**X5 ITP1601398/79 AQ+ COVID-19 Ag Rapid Test ITP160424 refs98/79 AQ+ COVID-19 Ag Rapid Test ITP1604498/79 AQ+ COVID-19 Ag Rapid Test ITP16044-TC25-98/79 AQ+Rapid SARS-CoV-19/ Flu Combo Test ITP160503 refs98/79 15 others COVID-19/FluA&B/RSV Ag Combo Rapid Test ITP18260398/79 ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test ITP710023 refs98/79 ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST ITP030042 refs98/79 One Step Dengue NS1 Ag Test ITP7100398/79 ONE STEP Malaria(p.f.) Test ITP110022 refs98/79 ONE STEP Malaria(p.f/p.v) Tri-line Test ITP110032 refs98/79 Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test ITP710044 refs98/79 Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test ITP7100598/79 Rapid Flu A Test ITP08100198/79 Rapid Flu A/B Test ITP08100398/79 Rapid Flu B Test ITP08100298/79 Rapid Malaria Test (P.f/Pan) ITP110052 refs98/79 Rapid Rota-Adenovirus Combo Test ITP1400398/79 Rapid SARS-CoV-2 Antigen Test ITP160103 refs98/79 Rapid SARS-CoV-2 Antigen Test ITP1601398/79	– 98/79	Website EUDAMED record Report an error
Mpbio FDA EU representative : MP Biomedicals Germany GmbH (Germany)	Germany, Singapore	Dengue NS1 Antigen Rapid Test98/79 MP Diagnostics ASSURE H. pylori Antigen Rapid Test98/79 MP Diagnostics ASSURE H. pylori Rapid Test98/79 MP Diagnostics HBsAg ELISA 4.1 23470-096 (96 wells)98/79 MP Diagnostics HBsAg ELISA 4.1 23470-480 (480 wells)98/79 15 others MP Diagnostics MULTISURE HIV Rapid Test98/79 MP Diagnostics MULTISURE® Dengue Ab/Ag Rapid Test98/79 Rapid 2019-nCoV IgG/IgM Combo Test Card98/79 Rapid H.pylori Antigen Test Card98/79 Rapid Influenza A + B Antigen Test Card98/79 Rapid Influenza A Antigen Test Card98/79 Rapid SARS-CoV-2 Antigen Test Card2 refs98/79 Rapid SARS-CoV-2 Antigen Test Card (1 Test Box)98/79 Rapid SARS-CoV-2 Antigen Test Card (1 test per box NL)98/79 Rapid SARS-CoV-2 Antigen Test Card (20 tests per box)98/79 Rapid SARS-CoV-2 Antigen Test Card (5 tests per box)98/79 Rapid SARS-CoV-2 Antigen Test Card (5 tests per box, NL)98/79 Rapid SARS-CoV-2 Antigen Test Card (7 tests per box)98/79 Rapid SARS-CoV-2 Antigen Test Card (8 tests per box)98/79 Rapid SARS-CoV-2 Influenza A+B Antigen Duo Test Card98/79	– 98/79	Website EUDAMED record Report an error
Citest Diagnostics EU representative : VidaQuick Biotech S.L. (Spain)	Canada	Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICD-635B98/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette (Feces) ICD-635B(CT)98/79 H. pylori Antibody Rapid Test Cassette IHP-302(CT)98/79 H.pylori Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) IHP-40298/79 H.pylori Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) IHP-402(CT)98/79 14 others H.pylori Antigen Rapid Test Cassette (Feces) IHP-60298/79 H.pylori Antigen Rapid Test Cassette (Feces) IHP-602(CT)98/79 Influenza A+B Rapid Test Cassette (Swab/Nasal Aspirate)98/79 Influenza A+B Rapid Test Cassette IIN-502(CT)98/79 MONO Rapid Test Cassette (WB/S/P)98/79 Mycoplasma pneumoniae IgM Test Cassette (Whole Blood/Serum/Plasma)98/79 RSV Rapid Test (Nasopharyngeal swab/Nasal Aspirate)98/79 RSV Rapid Test Cassette IRS-502(CT)98/79 S. pneumoniae Antigen Rapid Test Cassette ISP-102(CT)98/79 Strep A Rapid Test Cassette (Throat Swab)98/79 Strep A Rapid Test Cassette IST-502(CT)98/79 Streptococcus pneumoniae Test Cassette (Urine/Cerebral Spinal Fluid)98/79 Syphilis Rapid Test Cassette (WB/S/P)98/79 Syphilis Rapid Test Cassette ISY-402(CT)98/79	– 98/79	ra02@citestdiagnostics.com EUDAMED record Report an error
Wizbiotech EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Diagnostic Kit for Antibody Subtype to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)98/79 Diagnostic Kit for Antibody to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)98/79 Diagnostic Kit for Antibody to Helicobacter Pylori(Colloidal Gold)98/79 Diagnostic Kit for Antigen to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)98/79 Diagnostic Kit for Antigen to Helicobacter Pylori (Latex)98/79 14 others Diagnostic Kit for Antigen to Rotavirus/Adenoviruses (Latex)98/79 Diagnostic Kit for Antibody to Treponema Pallidum(Colloidal Gold)98/79 Diagnostic Kit for Antigen to Respiratory Syncytial Virus (Colloidal Gold)98/79 Malaria (P.F) Rapid Test (Colloidal Gold)98/79 Malaria P.F/P.V Rapid Test (Colloidal Gold)98/79 Malaria P.F/Pan Rapid Test(Colloidal Gold)98/79 SARS-CoV-2 Ab Rapid Test (Colloidal Gold)98/79 SARS-CoV-2 Antigen Rapid Test98/79 SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)98/79 SARS-CoV-2 Antigen Rapid Test (Saliva)98/79 SARS-CoV-2 Antigen Rapid Test (Sputum/Saliva/Stool)98/79 SARS-CoV-2 Neutralizing Antibodies Test98/79 Type A, Type B98/79 Type A, Type B, Type C98/79	– 98/79	EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	ACON HIV 1/2/O Tri-line Rapid Test Cassette (Serum/Plasma/Whole blood)3 refs ACON SARS-CoV-2 IgG/IgM Rapid Test2 refs98/79 FIAflex2 refs98/79 FIAflex Dengue NS1 Ag FIA Test98/79 FIAflex SARS-CoV-2 & Influenza A/B Ag Combo FIA98/79 13 others FIAflex SARS-CoV-2 Antigen FIA98/79 Flowflex14 refs98/79 Flowflex Dengue NS1 Ag & IgG/IgM Combo Rapid Test Cassette (Serum/Plasma/Whole Blood)98/79 Flowflex Dengue NS1 Ag FIA Test98/79 Flowflex SARS-CoV-2 & Flu A/B & RSV & Adenovirus Antigen Combo Rapid Test98/79 Flowflex SARS-CoV-2 & Influenza A/B Ag Combo FIA98/79 Flowflex SARS-CoV-2 & Influenza A/B Ag Combo Rapid Test4 refs98/79 Flowflex SARS-CoV-2 Antigen FIA98/79 Flowflex SARS-CoV-2 Antigen Rapid Test4 refs98/79 Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)2 refs98/79 Flowflex SARS-CoV-2 Antigen Rapid Test Slim2 refs98/79 Influenza A/B Rapid Test (Self-Testing) L031-1193598/79 Quik-Check7 refs98/79	D IVDR, 98/79	Website EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Dengue Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)4 refs98/79 Dengue IgG/IgM Antibody Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)4 refs98/79 H.Pylori Antibody (H.p Ab) Diagnostic Kit (Immunochromatographic Assay)2 refs98/79 Helicobacter pylori Antigen (Hp-Ag) Diagnostic Kit (Immunochromatographic Assay)2 refs98/79 Malaria Pf/ Pv Antigen Test Kit (Immunochromatographic Assay)2 refs98/79 13 others Respiratory 13 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 Respiratory 9 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 Respiratory Bacteria & M.P 6 Antigen Combo Test Kit (Immunochromatographic Assay)2 refs98/79 Respiratory Virus, Bacteria & M.P 10 Antigen Combo Test Kit (Immunochromatographic Assay)2 refs98/79 Respiratory Virus, Bacteria & M.p 11 Antigen Combo Test Kit (Immunochromatographic Assay)2 refs98/79 Respiratory Virus, Bacteria & M.P 14 Antigen Combo Test Kit (Immunochromatographic Assay)2 refs98/79 SARS-CoV-2 & Influenza A/B & RSV /ADV/hMPV Antigen Combo Test Control98/79 SARS-CoV-2 & Influenza A/B & RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 SARS-CoV-2 & Influenza A/B Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)98/79 SARS-CoV-2/RhV/PIV & Influenza A/B & RSV /ADV/hMPV Antigen Combo Test Control98/79 SARS-CoV-2/RhV/PIV & Influenza A/B & RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 SARS-CoV-2/RhV/PIV/Influenza A/B / RSV/ADV/hMPV/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 Strep A antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
Nexlab EU representative : MedNet EC-REP GmbH (Germany)	China	POCBio COVID-19/Flu A&B Combo Rapid Test LATR04-C2598/79 POCBio COVID-19/FluA/FluB/RSV 4 in 1 Rapid Test LATR05-C2598/79 POCBio Dengue IgM/IgG Rapid Test LATT02-C2598/79 POCBio Dengue IgM/IgG Rapid Test LATT02-C5098/79 POCBio Dengue NS1 and IgM/IgG Combo Rapid Test LATT07-C2598/79 13 others POCBio Dengue NS1 Antigen Rapid Test LATT01-C2598/79 POCBio Dengue NS1 Antigen Rapid Test LATT01-C5098/79 POCBio Flu A/B Rapid Test LATR01-C2598/79 POCBio Malaria Pf Rapid Test LATT03-C2598/79 POCBio Malaria Pf Rapid Test LATT03-C5098/79 POCBio Malaria Pf/Pan Rapid Test LATT05-C2598/79 POCBio Malaria Pf/Pan Rapid Test LATT05-C5098/79 POCBio Malaria Pf/Pv Rapid Test LATT04-C2598/79 POCBio Malaria Pf/Pv Rapid Test LATT04-C5098/79 POCBio Rota/Adenovirus Combo Rapid Test LATG03-C2598/79 POCBio SARS-CoV-2 Antigen Rapid Test LATR03-C2598/79 POCBio Syphilis Antibody Rapid Test LATB04-C2598/79 POCBio Syphilis Antibody Rapid Test LATB04-C5098/79	– 98/79	EUDAMED record Report an error
Phasescientific FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Hong Kong SAR China	INDICAID™ Candida/Trichomonas Vaginalis/Gardnerella Vaginalis Rapid Antigen Test98/79 INDICAID™ Dengue Virus Rapid Antibody Test98/79 INDICAID™ GASTROINTESTINAL 3-in-1 Rapid Antigen Test98/79 INDICAID™ Helicobacter pylori Rapid Antigen Test98/79 INDICAID™ Helicobacter pylori Rapid IgG Antibody Test98/79 13 others INDICAID™ HPV Virus Staining Test98/79 INDICAID™ Multiple Respiratory Pathogen Rapid Antigen Test98/79 INDICAID™ Respiratory 12-in-1 Rapid Antigen Test98/79 INDICAID™ Respiratory 12-in-1 Rapid Antigen Test (Children Edition)98/79 INDICAID™ Respiratory 5-in-1 Rapid Antigen Test98/79 INDICAID™ Respiratory 6-in-1 Rapid Antigen Test98/79 INDICAID™ Respiratory 8-in-1 Rapid Antigen Test98/79 INDICAID™ Rotavirus/Adenovirus Rapid Antigen Test98/79 INDICAID™ Strep A Rapid Antigen Test98/79 INDICAID™Dengue Virus Rapid NS1 Antigen Test98/79 INDICAID™Strep B Rapid Antigen Test98/79 INDICAID™Treponema Pallidum Rapid Antibody Test98/79 P0098, P009998/79	– 98/79	Website info@phasesci.com EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Luxus Lebenswelt GmbH (Germany) and 2 others	China	Dengue IgG/IgM Antibody Test Kit Cassette DENG/M1W-198/79 Dengue IgG/IgM Antibody Test Kit Cassette DENG/M1W-2598/79 Dengue IgG/IgM Antibody Test Kit Cassette DENG/M1W-598/79 Dengue IgG/IgM Antibody Test Kit Strip DENG/M2W-5098/79 Dengue NS1 & IgG/IgM Combo Test Ki Cassette3 refs98/79 11 others Dengue NS1 Antigen Test Kit Cassette4 refs98/79 Dengue NS1 Antigen Test Kit Strip98/79 Group A Streptococcus Antigen Test Kit Cassette Strip2 refs98/79 Group A Streptococcus Antigen Test Kit Strip98/79 H.Pylori Antigen Test Kit Cassette Tube Strip HPAg1FEST-13 refs Influenza A+B Antigen Test Kit (Colloidal Gold) Cassette2 refs98/79 Malaria pf Test Kit Cassette98/79 Malaria pf/pan Test Kit Cassette98/79 Malaria pf/pv Test Kit Cassette4 refs98/79 Malaria pf/pv Test Kit Strip98/79 Strep A Antigen Test Kit Cassette GAS1TST-13 refs	C IVDR, 98/79	sales@dbluemedical.com EUDAMED record Report an error
Clongene FDA EU representative : HUMISS TRADING S. L. (Spain) and 1 other	China	Dengue IgG/IgM Rapid Test Cassette (WB/S/P) IDAB421298/79 Dengue IgG/IgM-NS1 Combo Rapid Test Cassette (WB/S/P) IDEN432598/79 Dengue NS1 Antigen Rapid Tests IDAG4001, IDAG400298/79 H.pylori Antibody Rapid Tests IHPB4001, IHPB400298/79 H.pylori Antigen Rapid Test Cassette (Feces) IrHPG600298/79 11 others Influenza A+B Rapid Test IFLUn212, IFLUn21898/79 Legionella pneumophila Antigen Rapid Test ILP100298/79 Malaria P.f Antigen Rapid Test Cassette (WB) IPFGi00298/79 Malaria P.f/P.v Antigen Rapid Test Cassette (WB) IFVGi2198/79 Malaria P.f/Pan Antigen Rapid Test Cassette (WB) IFPGi212, IFPGi21898/79 Malaria Pan Antigen Rapid Test Cassette (WB) IPANi00298/79 Monkeypox Virus Antigen Rapid Test IMPX000298/79 RSV Antigen Rapid Test Cassette (Swab) IRSVn002, IRSVn00898/79 Streptococcus pneumoniae Antigen Rapid Test ISP100298/79 Strep A Rapid Tests ISAp001 ISAp002 ISAp00898/79 Syphilis Rapid Tests ITP4001, ITP400298/79	– 98/79	Website marketing@clongene.com EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	Cholera Ag Rapid Test Kit98/79 Clostridium Difficile Related Test Kit Ir04298/79 COVID-19 (2019n-Cov) Antigen Detection Kit98/79 Dengue Ab IgM/IgG Test Kit Ir02698/79 Dengue Ag NS1 Test Kit98/79 11 others Dengue NS1/IgM/IgG Test Panel98/79 H.Pylori Ab Test Kit Ir03098/79 H.Pylori Ag Test Kit Ir03198/79 HSV Herpes Simplex Virus Ab Test Kit Ir05998/79 Influ A+B/ADV/RSV Ag 4-in-1 Test Panel98/79 Influenza A+B Ag Test Kit Ir04398/79 Mycoplasma Pneumoniae Ab Test Kit Ir04798/79 Norovirus GI/GII Antigen Detection Kit98/79 Rotavirus Ag Test Kit Ir03498/79 RSV Respiratory Syncytial Virus Ag Test Kit Ir04598/79 Strep A Ag Test Kit Ir04498/79	– 98/79	EUDAMED record Report an error
Abon Biopharm(Hangzhou) EU representative : Medical Technology Promedt Consulting GmbH (Germany)	China	Chlamydia Rapid Test Device (Swab/Urine) ICH-50298/79 Clearview™ Strep A Dipstick 2 IST-50198/79 Clearview™ Strep A Cassette 2 IST-50298/79 ICH-50298/79 IHBsg-40298/79 10 others IHC-30298/79 IHI-T40298/79 IHP-30298/79 IHP-40298/79 IHP-60298/79 IIN-50198/79 IST-50198/79 IST-50298/79 ISY-U40198/79 ISY-U40298/79	– 98/79	EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	Biobase COVID-19 Antigen Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Biobase COVID-19 Antigen Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79 Combined Detection Kit For Influenza A/B (Colloidal Gold) 20 tests / kit98/79 Combined Detection Kit For Influenza A/B (Colloidal Gold) 25 tests / kit98/79 Dengue Rapid Test Kit（Colloidal Gold） 20 tests / kit98/79 9 others Dengue Rapid Test Kit（Colloidal Gold） 25 tests / kit98/79 Helicobacter Pylori Antibody Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Helicobacter Pylori Antibody Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79 Helicobacter pylori antigen Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Helicobacter pylori antigen Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79 Malaria P.Falciparum/P.Vivax Rapid Test Kit（Colloidal Gold） 20 tests / kit98/79 Malaria P.Falciparum/P.Vivax Rapid Test Kit（Colloidal Gold） 25 tests / kit98/79 Respiratory syncytial virus Antigen Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Respiratory syncytial virus Antigen Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79	– 98/79	EUDAMED record Report an error
Biomaxima	Poland	Clostridium difficile GDH kasetki 20 szt2 refs Clostridium difficile GDH+A+B kas. 20szt Denga Ab/Ag / Dengue Ab/Ag Dengue - kasetki 20 szt. Dengue NS1 kasetki 20 szt. 9 others H. pylori Ab - kasetki 20 szt. H. pylori Ag w kale - kasetki 20 szt. Influenza A+B kas. 20 szt. Malaria P.f./Pan 1-352-K02098/79 Mononukleoza / Mononucleosis RPR Carbon (+kontrola / +control) RPR Carbon bez kontroli 100 ozn.2 refs RSV + Adeno-resp. - kasetki 20 szt. RSV - kasetki 20 szt. Syfilis / Syphilis Syfilis kasetki 40 szt.2 refs	B, C IVDR, 98/79	Website info@biomaxima.com EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	Dengue IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(ab)-402c98/79 Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(NS)-402c98/79 Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(NS)-402d98/79 Dengue NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN-425a98/79 H. pylori Ab Rapid Test Cassette (Serum/Plasma) GCHP-302a98/79 8 others H. pylori Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHP-402a98/79 H. pylori Ag Rapid Test Cassette (Feces) GCHP-602a98/79 Human Parainfluenza Virus Type I / III and Adenovirus Detection Kit (Fluorescence PCR) APA0198/79 Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pv)-402a98/79 Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pan)-402a98/79 One Step Microalbumin Test Cassette (Urine) GIHSA-102a98/79 Rapid SARS-CoV-2 RNA test RCOV0198/79 Syphilis Ab Rapid Test Cassette (Serum/Plasma) GCSYP-302a98/79	– 98/79	sales@orientgene.com EUDAMED record Report an error
Sejoy FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Dengue IgG/IgM Rapid Test Device Cassette98/79 Dengue IgG／IgM／NS1 Combo Rapid Test Cassette98/79 Dengue NS1 Antigen Rapid Test Cassette98/79 H.pylori Antibody Rapid Test Cassette98/79 Influenza A+B Rapid Test Cassette98/79 8 others ISIRA-944598/79 ISIRAH-965598/79 Malaria P.f ＆P.v Rapid Test (Whole Blood) Cassette98/79 Malaria P.f ＆Pan Rapid Test (whole blood) Cassette98/79 Malaria Plasmodium Falciparum Rapid Test (whole blood) Cassette98/79 SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test Cassette98/79 SARS-CoV-2 & Influenza A/B & Respiratory Syncytial Virus & HMPV Antigen Combo Test Kit98/79 Syphilis Antibody Rapid Test Cassette,Strip98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Dengue IgG/IgM FIA Kit 25 Tests/kit98/79 Dengue NS1 Ag FIA Kit 25 Tests/kit98/79 Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method) 100 Tests/kit98/79 Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method) 25 Tests/kit98/79 Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method) 50 Tests/kit98/79 8 others Flu A & Flu B Antigen Rapid Detection Kit (Lateral Flow Method) 100 Tests/kit98/79 Flu A & Flu B Antigen Rapid Detection Kit (Lateral Flow Method) 25 Tests/kit98/79 Flu A & Flu B Antigen Rapid Detection Kit (Lateral Flow Method) 50 Tests/kit98/79 Influenza A/B Virus Antigen Detection Kit(Fluorescence Immunoassay) 25 Tests/kit98/79 Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 100 Tests/kit98/79 Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 25 Tests/kit98/79 Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 50 Tests/kit98/79 RSV FIA Kit 25 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Artronlab FDA EU representative : MedNet EC-REP GmbH (Germany)	Canada	Acmex Hepatitis B Surface Antigen (HBsAg) Test Cassette2 refs Acmex Hepatitis C Virus (HCV) Antibody Test Cassette2 refs Acmex Human Immunodeficiency Virus 1/2 (HIV1/2) Antibody Test Cassette2 refs Acmex Treponema Pallidum (TP) Antibody Test Cassette2 refs Artron Dengue NS1 Antigen Test Cassette98/79 7 others Artron Helicobacter Pylori (HP) Antibody Test cassette98/79 Artron Helicobacter pylori (HP) Antigen Test Cassette98/79 Artron Hepatitis B Virus Surface Antigen (HBsAg) Test Cassette98/79 Artron Hepatitis C Virus (HCV) Antibody Test cassette98/79 Artron Human lmmunodeficiency Virus 1/2 (HMl2l Antibody Test Cassette98/79 Artron One Step Treponema Pallidum (TP) Antibody Test Cassette2 refs98/79 Artron One Step Treponema Pallidum (TP) Antibody Test Strip98/79	C, D IVDR, 98/79	Website info@artronlab.com EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany)	China	CMV Cytomegalovirus Antibody IgG Rapid Test (Colloidal Gold)98/79 CMV Cytomegalovirus Antibody IgM/IgG Rapid Test Kit (Colloidal Gold)98/79 Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold)98/79 Flu A+B/MP Antigen Rapid Test98/79 Influenza A Antigen Rapid Test H1919-21S98/79 7 others Influenza B Antigen Rapid Test H1918-21S98/79 Malaria P.f (HRP2, pLDH) Rapid Test98/79 Malaria P.f/P.v/Pan Rapid Test H1433-41W98/79 Mpox Virus Antigen Rapid Test H200S98/79 SARS-CoV-2 Antigen Rapid Test98/79 Strep A Antigen Rapid Test (Immunochromatography)98/79 Streptococcus Pneumoniae Antigen Rapid Test98/79	– 98/79	Website EUDAMED record Report an error
Labnovation EU representative : MedNet EC-REP GmbH (Germany)	China	Dengue IgG/IgM Antibody Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Dengue NS1 Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Dengue NS1&IgG/lgM Rapid Test (Immunochromatography) 20 Tests/Kit98/79 H. Pylori Antibody Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 H. Pylori Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 7 others Influenza A/B Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Malaria P.f (HRP-2) Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Malaria P.f (HRP-2)/P.v (LDH)/Pan (LDH) Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Monkeypox Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 SARS-CoV-2 Antigen and Influenza A/B Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Treponema Pallidum Antibody Rapid Test kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	Website info@labnovation.com EUDAMED record Report an error
Operon FDA	Spain	Simple / Stick Strep A 9.134.XXX.YY.ZZZ3 refs SIMPLE 2A-Bdiff / STICK 2A-Bdiff 9.038.XXX.YY.ZZZ98/79 Simple AG SARS-CoV-2 / Flu A+B 9.242.XXX.YY.ZZZ3 refs Simple Flu A+B 9.080.XX.YYY.ZZZ3 refs SIMPLE GDH / STICK GDH 9.045.XXX.YY.ZZZ3 refs 7 others Simple GDH-Toxins 9.065.XXX.YY.ZZZ3 refs Simple H.pyl / Stick H.pyl 9.076.XXX.YY.ZZZ98/79 SIMPLE Legio pneumo / STICK Legio pneumo 9.106.XXX.YY.ZZZ98/79 Simple RSV 9.064.XXX.YY.ZZZ3 refs Simple RSV-Flu A+B 9.081.XXX.YY.ZZZ3 refs SIMPLE Strep pneumo / STICK Strep pneumo 9.107.XXX.YY.ZZZ98/79 VIRAPID® HELICOBACTER PYLORI/TRANSFERRIN Ag 9.231.XXX.YY.ZZZ3 refs	B IVDR, 98/79	Website infoeudamed@operon.es EUDAMED record Report an error
Reagen EU representative : CMC Medical Devices & Drugs SL (Spain)	China	COVID-19 & Influenza A/B Antigen Combo Test Kit98/79 Eleven Respiratory Pathogens Antigen Rapid Test Kit 20T98/79 Eleven Respiratory Pathogens Antigen Rapid Test Kit （NPS) 20T98/79 Nine Respiratory Pathogens Antigen Rapid Test Kit 1T98/79 Nine Respiratory Pathogens Antigen Rapid Test Kit 20T98/79 7 others SARS-CoV-2/RSV&Flu A/B Antigen Rapid Test Kit 1T98/79 SARS-CoV-2/RSV&Flu A/B Antigen Rapid Test Kit 20T98/79 SARS-CoV-2/RSV/ADV/MP&Flu A/B Antigen Rapid Test Kit 1T98/79 SARS-CoV-2/RSV/ADV/MP&Flu A/B Antigen Rapid Test Kit 20T98/79 Ten Respiratory Pathogens Antigen Rapid Test Kit 1T98/79 Ten Respiratory Pathogens Antigen Rapid Test Kit 20T98/79 Twelve Respiratory Pathogens Antigen Rapid Test Kit 1T98/79	– 98/79	Website info@reagenus.com EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	2019-nCoV Antigen Test (Lateral Flow Method)3 refs One Step Chlamydia Swab / Urine Test98/79 One Step Influenza A Test4 refs98/79 One Step Influenza A&B Test2 refs98/79 One Step Influenza B Test4 refs98/79 7 others One Step Strep A Swab Test3 refs98/79 Respiratory Syncytial Virus Antigen Test W773P000198/79 Respiratory Syncytial Virus Antigen Test W773P000298/79 Respiratory Syncytial Virus Antigen Test W773P000398/79 Respiratory Syncytial Virus Antigen Test W773P000498/79 Respiratory Syncytial Virus Antigen Test W773P000598/79 Wondfo One Step HIV1/2 Whole Blood/Serum/Plasma Test2 refs	C, D IVDR, 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
Certest	Spain	CerTest C. difficile GDH+Toxin A+B3 refs CerTest Clostridium difficile antigen GDH3 refs CerTest Clostridium difficile Toxin A+B3 refs CerTest H. pylori3 refs CerTest Influenza A+B3 refs 6 others CerTest Legionella CerTest RSV3 refs CerTest S. pneumoniae CerTest SARS-CoV-23 refs CerTest SARS-CoV-2+ Flu A + Flu B3 refs CerTest SARS-CoV-2+ Flu A + Flu B + RSV3 refs	B, C IVDR	Website quality@certest.es EUDAMED record Report an error
Nano Diagnosis for Health Biotech (Guangzhou) EU representative : MedPath GmbH (Germany)	China	Covid-19 + Influenza A/B + RSV Combo Rapid Test98/79 Covid-19 + Influenza A/B Combo Rapid Test98/79 Dengue IgG/IgM Rapid Test DENAB-0298/79 Dengue NS1 + IgG/IgM Combo Rapid Test98/79 Dengue NS1 Antigen Rapid Test98/79 6 others H.Pylori Antibody Rapid Test HPAB-0298/79 H.Pylori Antigen Rapid Test HPAG-01、HPAG-0298/79 Malaria P.f./P.v. Rapid Test MALAC1-0298/79 Malaria P.f./P.v./Pan Rapid Test MALAC3-0298/79 Malaria P.f./Pan Rapid Test MALAC2-0298/79 Syphilis Rapid Test SYP-01、SYP-0298/79	– 98/79	EUDAMED record Report an error
PRIMA Lab EU representative : QbD RepS BV (Belgium)	Switzerland	800062-x98/79 Autotest Helicobacter pylori98/79 Autotest HIV 1/298/79 Dr. Max Helicobacter pylori test 800017-x98/79 GetTested HIV TEST98/79 6 others GetTested STREP A TEST98/79 HIV 1/2 SELF-TEST98/79 Horny Hive HIV Selbsttest98/79 PRIMA HOME TEST HIV 1/2 SELF-TEST98/79 TEST AUTODIAGNOSTICO HELICOBACTER PYLORI98/79 Veneris Test rapid HIV 1&298/79	– 98/79	quality@primahometest.com EUDAMED record Report an error
Aaz Productions Le Materiel Biomedical	France	ALL IN QUADRIPLEX®98/79 autotest COVID-VIRO ALL IN®5 refs98/79 autotest COVID-VIRO®9 refs98/79 autotest VIH® 2nd GENERATION3 refs COV-GRIP98/79 5 others COVID-VIRO98/79 SYPHILIS ALL IN® TR-SYP-00198/79 TetaQuick98/79 TROD'ANGINE2 refs98/79 TROD'DENGUE98/79	D IVDR, 98/79	EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other	China	1 test/kit21 refs98/79 25 tests/kit21 refs98/79 GeneSign Chikungunya Antigen Rapid Test 1 test/kit98/79 GeneSign Chikungunya Antigen Rapid Test 25 tests/kit98/79 GeneSign Chikungunya IgG/IgM Rapid Test 1 test/kit98/79 5 others GeneSign Chikungunya IgG/IgM Rapid Test 25 tests/kit98/79 GeneSign Dengue NS1/ZIKA/CHIKV Antigen Rapid Test 1 test/kit98/79 GeneSign Dengue NS1/ZIKA/CHIKV Antigen Rapid Test 25 tests/kit98/79 GeneSign Malaria P.f/P.v Ab Rapid Test 1 test/kit98/79 GeneSign Malaria P.f/P.v Ab Rapid Test 25 tests/kit98/79	– 98/79	info@genesignbio.com EUDAMED record Report an error
Widufit	Germany	STREP A Rapid Test WIB-SA-K98/79 STREP A Rapid Test WIB-SA-S98/79 STREP B Rapid Test B-SB98/79 STREP B Rapid Test B-SB-K98/79 STREP B Rapid Test B-SB-S98/79 5 others STREP B Rapid Test WIB-SB-K98/79 STREP B Rapid Test WIB-SB-S98/79 WiduMed Strep A Kassettentest98/79 WiduMed Strep A Streifentest98/79 WiduMed Strep B Kassettentest98/79	– 98/79	Website info@widufit.de EUDAMED record Report an error
Xenta Biomedical Science FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	COVID-19 Antigen Rapid Detection Kit (Nasal Swab)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (NP Swab)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (Saliva Lollipop)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (Saliva)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (Throat Swab)2 refs98/79 5 others IFA & IFB & COVID-19 Antigen Joint Detection Kit (Immunochromatography Assay)2 refs98/79 IFA & IFB Antigen Joint Detection Kit (Immunochromatography Assay)2 refs98/79 Malaria Antigen P.f Detection Reagent (Colloidal Gold method)2 refs98/79 Malaria Antigen P.f/P.v Detection Reagent (Colloidal Gold method)2 refs98/79 Malaria Antigen P.f/Pan Detection Reagent (Colloidal Gold method)2 refs98/79	– 98/79	Website EUDAMED record Report an error
Anhui Formaster Biosci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	H. pylori Antigen Rapid Test (Feces) IHP-301398/79 Influenza A&B/Adeno/RSV/COVID-19 Antigen98/79 Influenza A&B/Adeno/RSV/COVID-19/MP Antigen Rapid Test98/79 Influenza A&B/COVID-19 Antigen Combo Rapid Test98/79 Influenza A&B/RSV/COVID-19 Antigen Rapid Test98/79 4 others RSV Rapid Test IRS-101398/79 Strep A Rapid Test (Swab) ISA-101398/79 Strep B Rapid Test (Swab) ISB-101398/79 Syphilis Rapid Test (Whole Blood/Serum/Plasma) ISY-501398/79	– 98/79	Website EUDAMED record Report an error
Hangzhou Genesis Biodetection Biocontrol FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Dengue IgG/IgM Rapid Test Device P23110698/79 EBNA IgG Rapid Test P23111798/79 EBV-VCA IgG Rapid Test P23111698/79 Flu A+B Antigen Rapid Test Device P21210298/79 Flu A+B Antigen Rapid Test P21100298/79 8 others Legionella Antigen Rapid Test Device P24111098/79 RSV Antigen Rapid Test Device P21211298/79 Strep B Antigen Rapid Test P28100398/79 Dengue IgG/IgM/NS1 Combo Rapid Test Device P23110598/79 (no longer marketed) Dengue NS1 Rapid Test Device P23110498/79 (no longer marketed) Malaria Pf Antigen Rapid Test Device P23110798/79 (no longer marketed) Malaria Pf/Pan Antigen Rapid Test Device P23110998/79 (no longer marketed) Malaria Pf/Pv Antigen Rapid Test Device P23110898/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	Clostridioides difficile Detection and Monitoring Kit (24)3 refs98/79 Clostridioides difficile Detection and Monitoring Kit (48)3 refs98/79 Influenza-A Virus Detection and Monitoring Kit (24)3 refs98/79 Influenza-A Virus Detection and Monitoring Kit (48)3 refs98/79 Influenza-A Virus Detection and Monitoring Kit (96)3 refs98/79 3 others VZV Quantification Kit (24)3 refs98/79 VZV Quantification Kit (48)3 refs98/79 VZV Quantification Kit (96)3 refs98/79	– 98/79	Website EUDAMED record Report an error
Association Of Medicine Analytics EU representative : CMC Medical Devices & Drugs SL (Spain)	Russia	AMA DENT98/79 AMA RUT Expert98/79 AMA RUT Pro (48 in blocks)98/79 AMA RUT Pro (block of 24)98/79 AMA VENERA98/79 3 others HELIC ABT Reader indicator tube kit (1 pcs)98/79 HELIC ABT Reader indicator tube kit (30 pcs)98/79 HELIC ABT Reader indicator tube kit (50 pcs)98/79	– 98/79	Website EUDAMED record Report an error
Atlas Medical FDA	Germany	Atlas 8.04.37.0.002098/79 Atlas Adeno - RSV Respiratory Test Device, Nasopharyngeal Sample Individually Pouched, 20 Tests/Box 8.16.39.0.002098/79 Atlas H.pylori Antigen Test Cassette, Stool Sample, Individually Pouched, 20 Tests/Box (Buffer to be supplied in Extraction Tubes) 8.04.23.1.002098/79 Atlas H.pylori Antigen Test Strip, 3.5mm, Stool Sample, Individually Pouched, 25 Test/Box (Buffer to be supplied in Extraction Tubes) 8.04.24.1.002598/79 Atlas Influenza A&B Test Device, Nasopharyngeal Sample, Individually Pouched, 20 Tests/Box 8.04.86.0.002098/79 3 others Atlas Influenza A&B Test Device, Nasopharyngeal Sample, Individually Pouched, 25Tests/box 8.04.86.0.002598/79 Atlas Influenza A&B Test Strip, Nasopharyngeal Sample, Individually Pouched, 25 Tests/Box. 8.04.96.0.002598/79 Atlas Malaria PF/PV , test cassette, Whole blood, Individually packed, 20 Test/Box 8.16.14.0.002098/79	– 98/79	Website info@atlas-medical.com EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	H.Pylori Antibody Rapid Test 25Tests/Kit98/79 H.Pylori Antibody Rapid Test 50Tests/Kit98/79 Helicobacter Pylori (HP) Antigen Test Kit 1Test/Kit98/79 Helicobacter Pylori (HP) Antigen Test Kit 20Tests/Kit98/79 Helicobacter Pylori (HP) Antigen Test Kit 25Test/Kit98/79 3 others Syphilis Ab Combo Rapid Test 1Test/Kit98/79 Syphilis Ab Combo Rapid Test 25Tests/Kit98/79 Syphilis Ab Combo Rapid Test 50Tests/Kit98/79	– 98/79	Website EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain)	South Korea	Dengue IgG/IgM Rapid Test Cassette HIDC-402A98/79 Dengue NS1 Rapid Test Cassette98/79 H. pylori Antibody Rapid Test Cassette/Strip HIHP-402/HIHP-40198/79 H. pylori Antigen Rapid Test Cassette HIHPG-60298/79 Influenza A+B Rapid Test Cassette HIFL-52298/79 3 others Malaria P.f./Pan Rapid Test Cassette HIMPN-40298/79 Strep A Rapid Test Cassette/Strip HISTA-502/HISTA-50198/79 Syphilis Rapid Test Cassette/Strip HISY-402/HISY-40198/79	– 98/79	EUDAMED record Report an error
Vircell	Spain	VIRAPID® CLOSTRIDIUM DIFFICILE (GDH) Ag VRC004 VIRAPID® CLOSTRIDIUM DIFFICILE (GDH/TOX A/TOX B) Ag VRC005 VIRAPID® INFLUENZA A/INFLUENZA B Ag FIA VRF004 VIRAPID® LEGIONELLA CULTURE VR00298/79 VIRAPID® LEGIONELLA PNEUMOPHILA Ag FIA VRF002 3 others VIRAPID® MONO M&G VR00198/79 VIRAPID® RESPIRATORY SYNCYTIAL VIRUS Ag FIA VRF003 VIRAPID® STREPTOCOCCUS GROUP A Ag VRC003	B, C IVDR, 98/79	EUDAMED record Report an error
Chemtronbio EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others	China	Cassette 8022C98/79 Chemtrue ®® Influenza A+B Antigen Combo Rapid Test (Lateral Flow)98/79 Chlamydia Trachomatis Rapid Test 8001C01P25 Chlamydia Trachomatis Rapid Test Cassette 8001C98/79 HP Ag H.pylori Antigen Rapid Test 2 others Influenza A+B Antigen Combo Rapid Test 8062C01 Influenza A+B Antigen Combo Rapid Test Cassette 8010C98/79	B, C IVDR, 98/79	Website EUDAMED record Report an error
CorDx FDA EU representative : Medunion S.L. (Spain)	United States	CorDx Respiratory Antigen Combo Rapid Test (ADV/RSV + PIV/HMPV) Cassette CorDx Respiratory Antigen Combo Rapid Test (ADV/RSV) Cassette CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID + ADV/RSV + PIV/HMPV) Cassette CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID + ADV/RSV) Cassette CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID + PIV/HMPV) Cassette 2 others CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID) Cassette CorDx Respiratory Antigen Combo Rapid Test (PIV/HMPV) Cassette	C IVDR	EUDAMED record Report an error
Nanjing Leading Medical Technology EU representative : Medunion S.L. (Spain)	China	1 Test/Bag98/79 1 Test/Box98/79 25 Tests/Box98/79 50 Tests/Box98/79 level 12 refs98/79 2 others level 1+level 22 refs98/79 level 22 refs98/79	– 98/79	EUDAMED record Report an error
Shenzhen Kang Sheng Bao Bio-Technology EU representative : QbD RepS BV (Belgium)	China	Flu A & Flu B Rapid Test98/79 Flu A Rapid Test98/79 Flu B Rapid Test98/79 H.pylori Ab Rapid Test98/79 H.pylori Ag Rapid Test98/79 2 others RSV Rapid Test98/79 Strep A Rapid Test98/79	– 98/79	Website info@ksbbiotech.com EUDAMED record Report an error
Zetmedikal	Türkiye	SARS-CoV-2 IgG/IgM Rapid Antibody Test98/79 SOFTEC Dengue NS1 Rapid Test Kit98/79 SOFTEC Dengue NS1/IgG/IgM Combo Rapid Test Kit SFDNCB4098/79 SOFTEC Malaria P.f/P.v Rapid Test Kit98/79 SOFTEC SARS-CoV-2 Antigen Rapid Test (Nasal Swab)98/79 2 others SOFTEC SARS-CoV-2 Neutralizing Antibody Rapid Test98/79 SOFTEC Syphilis Rapid Test Kit (Cassette) SFSPRT4098/79	– 98/79	Website info@zetmedikal.com EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI Device:20 Test/Kit17 refs98/79 QINGLI Device:20 Test/Kit, Strip: 25Test/Kit QINGLI IST-501 (Strip) / IST-502 (Device)98/79 QINGLI Strip(ISY-401)98/79 QINGLI Strip: 25Test/Kit98/79 2 others QINGLI Strip: 25Tests/Kit9 refs98/79 Strep A Rapid Test Device IST-502s	C IVDR, 98/79	EUDAMED record Report an error
Avioq Bio-tech EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	1 Test/Kit98/79 2 Tests/Kit98/79 20 Tests/Kit98/79 25 Tests/Kit98/79 40 Tests/Kit98/79 1 other 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
BioChain (Beijing) Science & Technology EU representative : Medunion S.L. (Spain)	China	1 test/kit98/79 10 tests/kit2 refs98/79 100 tests/kit98/79 20 tests/kit2 refs98/79 5 tests/kit2 refs98/79 1 other 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Diasia FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	1 Test/kit98/79 10 Tests/kit98/79 100 Tests/kit3 refs98/79 25 Tests/kit4 refs98/79 5 Tests/kit98/79 1 other 50 Tests/kit4 refs98/79	– 98/79	Website EUDAMED record Report an error
Dutch Diagnostics	Netherlands	Dengue IgG/IgM Test98/79 H.Pylori Ab Test2 refs98/79 H.Pylori Ag Test98/79 Influenza A+B Test3 refs98/79 Strep A Test3 refs98/79 1 other TMS Strep A2 refs98/79	– 98/79	Website info@dutch-diagnostics.com EUDAMED record Report an error
Lifotronic FDA EU representative : Umedwings Netherlands B.V. (Netherlands)	China	Dengue IgG/IgM Antibody Test (GICA) 25T98/79 Dengue NS1 Antigen Test (GICA) 25T98/79 Dengue NS1/IgG/IgM Test (GICA) 25T98/79 H.Pylori Ag Test (GICA) 25 Tests/Kit98/79 Influenza A&B Test (GICA) 25T98/79 1 other Malaria P.f/Pan Test (GICA) 25T98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen Superbio Technology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	InFluA/InFluB Ag Rapid Test (Immunochromatography Assay)98/79 Monkeypox Virus (MPxV) Antigen Quality Control2 refs98/79 ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test (Colloidal Gold)2 refs98/79 ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold)2 refs98/79 Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Fluorescence Immunochromatographic Assay)98/79 1 other Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Immunochromatography Assay)98/79	– 98/79	info@sup-bio.com EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany)	Egypt	CMV IgG/IgM Rapid Test-Cassette98/79 H. pylori Ab Rapid Test Cassette (Serum, Plasma and Whole Blood)98/79 H. pylori Ab Test98/79 H. pylori Ag Rapid Test Cassette (Fecal Specimen)98/79 H. pylori Ag Test98/79 1 other Malaria Antigen Test Card2 refs98/79	– 98/79	Website EUDAMED record Report an error
Synthgene (Yixing) Health Technology EU representative : MedPath GmbH (Germany)	China	FluA/FluB Antigen Rapid Test Kit (Colloidal gold method)98/79 Monkeypox Virus Antibody Rapid Test Kit CR01598/79 Monkeypox Virus Antigen Rapid Test Kit CR01798/79 RSV Antigen Rapid Test Kit(Colloidal gold method)98/79 Strep A Antigen Rapid Test Kit (Colloidal gold method)98/79 1 other Strep B Antigen Rapid Test Kit(Colloidal gold method)98/79	– 98/79	sales@syngenebio.com EUDAMED record Report an error
Tisenc EU representative : QbD RepS BV (Belgium)	China	Tisenc Dengue Virus IgG Antibody (CLIA)4 refs98/79 Tisenc Dengue Virus IgM Antibody (CLIA)4 refs98/79 Tisenc Dengue Virus NS1 Antigen (CLIA)4 refs98/79 Wondfo Dengue Virus IgG Antibody (CLIA)4 refs98/79 Wondfo Dengue Virus IgM Antibody (CLIA)4 refs98/79 1 other Wondfo Dengue Virus NS1 Antigen (CLIA)4 refs98/79	– 98/79	Website EUDAMED record Report an error
Azubio Diagnostics EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Pen A46060H11 Pen A47660H11 Pen A48410H11 Pen A49560H11 Pen A4D660H11	C IVDR	EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruVue10 refs98/79 TruVue COVID-19 Antigen Rapid Test (LFA)98/79 TruVue COVID-19& Influenza A +B Antigen Combo Rapid Test (LFA)98/79 TruVue Dengue IgG/IgM/ NS1 Combo Rapid Test (LFA)98/79 TruVue Dengue NS1 Ag Rapid Test (LFA)98/79	– 98/79	EUDAMED record Report an error
Innovacon EU representative : MDSS GmbH (Germany)	United States	456482900098/79 456483900198/79 456484900198/79 456485900098/79 456487900198/79	– 98/79	EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland)	China	StrongStep® Influenza A Antigen Rapid Test 20 Tests/box98/79 StrongStep® Influenza A/ B Combo Antigen Rapid Test 20 Tests/box98/79 StrongStep® System Device for SARS-CoV-2 & Influenza A/ B Combo Antigen Rapid Test 20 Tests/box98/79 StrongStep® System Device for SARS-CoV-2,Influenza A/B & RSV Combo Antigen Rapid Test 20 Tests/box98/79 StrongStep®SARS-CoV-2 Antigen Rapid Test 25 Tests/box98/79	– 98/79	Website sales@limingbio.com EUDAMED record Report an error
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	LYSUN DEG-P21（25PCS）98/79 LYSUN HP-F21（25PCS）98/79 LYSUN MAL-W21- FV（25PCS）98/79 LYSUN STP-S21（25PCS）98/79 LYSUN SYP-W21（25PCS）98/79	– 98/79	EUDAMED record Report an error
Shenzhen Huian Biosci Technology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	1T/Kit11 refs98/79 20T/Kit12 refs98/79 5T/Kit6 refs98/79 REF206-00198/79 REF206-02098/79	– 98/79	info@huiantech.com EUDAMED record Report an error
Tauns EU representative : Emergo Europe B.V. (Netherlands)	Japan	Capilia Flu Neo 10T/Box98/79 Capilia Flu Neo 20T/Box98/79 Capilia RSV Neo 20T/Box98/79 Capilia RSV Neo Test Plate 10T/Box98/79 Positive Control Flu98/79	– 98/79	Website EUDAMED record Report an error
Zhejiang Wantaifu Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Bio-Firm WI-FLU-C82-1098/79 Bio-Firm WI-FLU-C82-2598/79 Bio·Firm WI-MICR-C43A-1098/79 Bio·Firm WI-MICR-C43A-2598/79 Fulscreen WI-FLU-C82A-2598/79	– 98/79	Website EUDAMED record Report an error
Actim FDA	Finland	Actim® Influenza A&B 32832ETAC98/79 Actim® Influenza A&B 32834ETAC98/79 Actim® Influenza A&B 32836ETAC98/79 Actim® Influenza A&B 32837ETAC98/79	– 98/79	Website support@actimtest.com EUDAMED record Report an error
Arkray FDA EU representative : Arazy Group GmbH (Germany)	India	Crystal Crystal 58IC104-25, 58IC104-50 Crystal Dengue NS1 PARAHIT-F VER. 1.0 Rapid Test for P. falciparum Malaria Device	B, C IVDR	Website EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) and 1 other	China	Monkeypox virus (MPXV) Antigen Rapid Test Cassette9 refs98/79 Multiplex Real-time PCR Diagnostic Kit for Rapid Detection of Six Diarrheal Viruses98/79 SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette98/79 SARS-CoV-2 Antigen Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
Bgi	Denmark	BGI 10 tests/kit2 refs98/79 BGI 25 tests/kit2 refs98/79 BGI 5 tests/kit2 refs98/79 BGI 50 tests/kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Calth EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	AllCheck Dengue Duo Card CHR07 AllCheck Dengue NS1 Ag Card CHR17 Allcheck Influenza A+B CHR0898/79 AllCheck Syphilis Anti-TP CHR20	C IVDR, 98/79	Website info@thecalth.com EUDAMED record Report an error
Cesna	Türkiye	H.PYLORI AB HIZLI TESTİ H.PYLORI AG HIZLI TESTİ RSV HIZLI TEST KİTİ STREP HIZLI TEST KİTİ KONTROLÜ	B IVDR	Website info@cesna.com.tr EUDAMED record Report an error
Dyonmed	Greece	DyonHpsA98/79 DyonMono98/79 Pylori test (1 test/box)98/79 Pylori test (10 tests/box)98/79	– 98/79	Website customerservice@dyonmedical.com EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	1 test/kit5 refs98/79 25 tests/kit3 refs98/79 50 tests/kit98/79 Cassette(25 tests/kit)98/79	– 98/79	info@fanttest.com EUDAMED record Report an error
GC Medical Science EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	GENEDIA Multi Influenza Ag Rapid Test Kit98/79 GENEDIA W COVID-19 Ag3 refs98/79 GENEDIA W COVID-19 Ag External Control Swab98/79 Greencare Flu 2 Influenza A&B Ag98/79	– 98/79	EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Influenza A H1N1(2009) Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79 Influenza A&B Rapid Test Cassette R084T020B0C098/79 Influenza A&B Rapid Test Cassette R501T020B0C098/79 Strep A Antigen Test Kit R226T020B0C098/79	– 98/79	EUDAMED record Report an error
Ortho-Clinical Diagnostics Summers Ridge San Diego EU representative : MDSS GmbH (Germany)	United States	QuickVue Influenza A+B Test2 refs98/79 Sofia 2 Flu + SARS Antigen FIA98/79 Sofia SARS FIA98/79 Sofia Strep A+ FIA 25T98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Shenzhen Lvshiyuan Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Flu A & Flu B & COVID-19 Ag Rapid Test Flu A & Flu B & RSV & COVID-19 Ag Rapid Test Kit (Colloidal Gold) HM003A3 SARS‐CoV‐2 Antigen Rapid Test Kit SARS‐CoV‐2 Antigen Rapid Test Kit (Colloidal Gold)	B IVDR	Website EUDAMED record Report an error
Singclean EU representative : SUNGO Europe B.V. (Netherlands)	China	Singclean Cassette：1 test/box2 refs98/79 Singclean Cassette：10 tests/box2 refs98/79 Singclean Cassette：20 tests/box2 refs98/79 Singclean Cassette：5 tests/box2 refs98/79	– 98/79	Website EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	India, South Korea	Q-NCOV-07G4 refs STANDARD™ Q COVID-19 Ag Home Test Q-NCOV-03G3 refs STANDARD™ Q HCV Ab Test QHCV01B2 refs STANDARD Q Malaria P.f/P.v Ag RK025-40 (no longer marketed)	B, C, D IVDR	Website EUDAMED record Report an error
Anbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	BOIRON A10013001D98/79 Group A Streptococcus Test Kit A0216700298/79 Influenza A/B Rapid Test Kit A0210500298/79	– 98/79	info@anbio.com EUDAMED record Report an error
Biohit FDA	Finland	BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 Control98/79 BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 UFT3004 refs98/79 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 quick test98/79	– 98/79	Website info@biohit.fi EUDAMED record Report an error
Biolytical FDA EU representative : Emergo Europe B.V. (Netherlands)	Canada	INSTI HCV Test Controls 90-106798/79 INSTI HIV-1/HIV-2 Test Controls 90-103698/79 INSTI T. pallidum Test Controls 90-103298/79	– 98/79	EUDAMED record Report an error
Dynamiker EU representative : Lotus NL B.V. (Netherlands)	China	20 tests98/79 20 tests (A)98/79 DNK-2103-198/79	– 98/79	Website marketing@dynamiker.com EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	Influenza A/B-Q Real Time PCR Kit G2M70602198/79 Malaria-Q Real-Time PCR Kit G2M70622198/79 VZV-Q Real-Time PCR Kit for Varicella-zoster virus G2M70582198/79	– 98/79	Website EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : Medunion S.L. (Spain)	China	COVID-19 /Flu A &B/ RSV/ADV Ag Combo Rapid Test HWTS-RT065A3 refs COVID-19/ Flu A&B Ag Rapid Test HWTS-RT200A3 refs RSV/ADV Ag Rapid Test HWTS-RT201A3 refs	C IVDR	marketing@hongweitest.com EUDAMED record Report an error
Jiangsu Medomics Medical Technology FDA EU representative : R Sight B.V. (Netherlands) and 1 other	China	Candida albicans/ Trichomonas vaginalis/ Gardnerella vaginalis antigen Combo Test Kit (LFIA)98/79 Candida albicans/ Trichomonas vaginalis/ Gardnerella vaginalis antigen Combo Test Kit (LFIA) 012113-01-02；012113-02-02 ；012113-05-02；012113-20-023 refs Group A streptococcus Rapid test Kit98/79	C IVDR, 98/79	Website info@medomics-dx.com EUDAMED record Report an error
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany)	China	Adenovirus & Rhinovirus & mycoplasma pneumoniae Nucleic Acid Detection Kit (Fluorescence PCR )5 refs98/79 Influenza A&B Nucleic Acid Detection Kit(RNA Amplification Lateral Flow)3 refs98/79 Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR)2 refs98/79	– 98/79	EUDAMED record Report an error
Kalians EU representative : MDSS GmbH (Germany)	Egypt	H. pylori Ab Rapid Test Cassette (Serum, Plasma and Whole Blood) D-793 00198/79 H. pylori Ag Rapid Test Cassette (Fecal Specimen)98/79 Malaria Antigen Test (Whole Blood) For Plasmodium falciparum & vivax98/79	– 98/79	EUDAMED record Report an error
Konsung FDA EU representative : Lotus NL B.V. (Netherlands)	China	Helicobacter pylori Antibody (IgG) Test Kit (Colloidal Gold)98/79 Helicobacter pylori Antigen Test kit (Colloidal Gold)2 refs98/79 Influenza A&B Rapid Test Kit (Colloidal Gold)2 refs98/79	– 98/79	info@konsung.com EUDAMED record Report an error
Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Sti	Türkiye	CERTAIN3 refs98/79 LABOQUICK4 refs98/79 SURELAB2 refs98/79	– 98/79	Website info@koroglugroup.com EUDAMED record Report an error
Meril Diagnostics FDA EU representative : Obelis s.a. (Belgium)	India	HIVFIND HIVSST-013 refs HIVWBS-01 HIVWBS-02 HIVWBS-03 HIVWBS-043 refs MERISCREEN HVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 HVWRPD-08 HVWRPD-09 HVWRPD-10 HVWRPD-11 HVWRPD-123 refs	D IVDR	Website ram.kanoje@merillife.com EUDAMED record Report an error
Neo-nostics (Suzhou) Bioengineering EU representative : Medunion S.L. (Spain) and 1 other	China	COVID 19 Antigen Test Kit (Colloidal Gold Method) SVRAG8998/79 Respiratory Infection Test Device(Nasal/Nasopharyngeal/Oropharyngeal/Serum/plasma/ whole blood) RES024298/79 Vaginitis and Sexually Transmitted Infection Test Device(Urogenital Swab/Serum/plasma/whole blood) VAG024398/79	– 98/79	EUDAMED record Report an error
Ningbo BESTest Bio-technology EU representative : SUNGO Europe B.V. (Netherlands)	China	1 test/kit98/79 25 tests/kit98/79 5 tests/kit98/79	– 98/79	EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany)	United States	Savanna RVP Control Set98/79 Savanna RVP Control Set (1-set)98/79 Savanna RVP Control Set (4-set)98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Pluslife EU representative : Medunion S.L. (Spain) and 1 other	China	Mycobacterium Tuberculosis Nucleic Acid Assay Control2 refs SARS-CoV-2/Influenza A/Influenza B/RSV Nucleic Acid Assay Control98/79 Strep A Nucleic Acid Assay Control CRM1010402-198/79	C IVDR, 98/79	Website ra@pluslife.com EUDAMED record Report an error
Premier Medical EU representative : Obelis s.a. (Belgium)	India	First Response HBsAg Card Test PI10FRC4 refs98/79 First Response HCV Card Test PI03FRC4 refs98/79 First Response HIV 1-2.O Card Test (Version 2.0 PI05FRC4 refs98/79	– 98/79	Website info@premiermedcorp.com EUDAMED record Report an error
R-Biopharm FDA	Germany	RIDA®Quick C. difficile GDH Toxin A/B Combi2 refs RIDA®QUICK Parasite Combi Control98/79 RIDA®QUICK Rotavirus/Adenovirus Combi Control98/79	B IVDR, 98/79	Website EUDAMED record Report an error
Vazyme EU representative : Obelis s.a. (Belgium) and 1 other	China	2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based） C6603C98/79 SARS-CoV-2 and Influenza A/B Virus Antigen Combined Detection Kit (Colloidal Gold-Based)98/79 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) C8611C98/79	– 98/79	EUDAMED record Report an error
Vitro FDA	Romania	HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA) VT-HPBSP-25 Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse Syphilis (Whole blood /Serum /Plasma) Rapid Test Cassette Test rapid Sifilis (sange total/ser/plasma) caseta	B, C IVDR	Website office@vitro.ro EUDAMED record Report an error
Human	Germany	Syphilis RPR Test3 refs98/79 Syphilis TPHA liquid98/79 IM Quick Test98/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Medunion S.L. (Spain)	China	Monkeypox Virus Ag Test Strip & Cassette AB331-2098/79 Monkeypox Virus IgM/IgG Ab Test Strip & Cassette AB330-2098/79	– 98/79	EUDAMED record Report an error
Beijing North Institute of Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	BNIBT RI003C98/79 BNIBT RI003C-2098/79	– 98/79	info@eugenebio.com EUDAMED record Report an error
Biobase Diagnostic Technology (Shandong) EU representative : Luxus Lebenswelt GmbH (Germany)	China	Biobase COVID-19 Antigen Rapid Test 20 Tests/kit98/79 Biobase COVID-19 Antigen Rapid Test 25 Tests/kit98/79	– 98/79	EUDAMED record Report an error
Biopanda	Northern Ireland	Dengue NS1 Rapid Test Cassette98/79 Malaria P.f. Rapid Test Cassette RAPG-MLR-00198/79	– 98/79	Website info@biopanda.co.uk EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany)	China	SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method)98/79 SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography)98/79	– 98/79	Website EUDAMED record Report an error
CTK Biotech FDA EU representative : MDSS GmbH (Germany)	United States	Aria Influenza A/B Ag Rapid Test R0187C2 refs Aria RSV Ag Rapid Test R0186C2 refs	B IVDR	Website info@ctkbiotech.com EUDAMED record Report an error
Cupidlimited FDA EU representative : Amstermed B.V. (Netherlands)	India	CupiKIT2 refs CupiKIT HIV 1 & 2 Antibody Test Kit	C, D IVDR	Website qa@cupidlimited.com EUDAMED record Report an error
Daltonbio EU representative : Medunion S.L. (Spain) and 1 other	China	/98/79 Influenza A/B Virus Antigen Detection Kit (Immunochromatographic Method)98/79	– 98/79	Website EUDAMED record Report an error
Diagnostics For Real World FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	United States	SAMBA III SCoV-2/Flu/RSV Test SAMBA III STI Ulcer Panel Test 7000-12	B, C IVDR	Website ra@drw-ltd.com EUDAMED record Report an error
Egyptian For Biotechnology-Spectrum Diagnostics EU representative : MDSS GmbH (Germany)	Egypt	H. pylori Ab Test 1180 00198/79 H. pylori Ag Test 1184 00198/79	– 98/79	Website info@spectrum-diagnostics.com EUDAMED record Report an error
Eurospital FDA	Italy	Helori FAST98/79 Helori Urease	B IVDR, 98/79	regulatory@eurospital.it EUDAMED record Report an error
Genobio Pharmaceutical FDA EU representative : Caretechion GmbH (Germany)	China	Influenza A&B Antigen Rapid Test (Colloidal Gold) VILFA-0198/79 Influenza A&B Antigen Rapid Test (Colloidal Gold) VILFA-2098/79	– 98/79	Website marketing@era-bio.com EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	H. pylori Fast Test Kit (Immunofluorescence Assay)98/79 RSV Fast Test Kit (Immunofluorescence Assay)98/79	– 98/79	EUDAMED record Report an error
Guangzhou Deaou Gene Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	4 tests/kit98/79 8 tests/kit98/79	– 98/79	EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	101A0201EY,101A0201ED98/79 101A0202EY98/79	– 98/79	ra.danwei@danwei-bio.com EUDAMED record Report an error
Hecin EU representative : Share info GmbH (Germany)	China	COVID-19/Flu A&B Rapid Antigen Test3 refs Influenza A&B Rapid Antigen Test RJ05-13 refs	B IVDR	EUDAMED record Report an error
Nanjing Synthgene Medical Technology FDA EU representative : Lotus NL B.V. (Netherlands)	China	Strep A Antigen Rapid Test Kit (Colloidal gold method) CR02398/79 Strep B Antigen Rapid Test Kit (Colloidal gold method) CR02998/79	– 98/79	Website sales@syngenebio.com EUDAMED record Report an error
Roche FDA	Germany	cobas lumira SARS-CoV-2 Ag Ultra4 refs cobas lumira SARS-CoV-2 Ag Ultra QC2 refs	B IVDR	Website EUDAMED record Report an error
Sekisui Diagnostics FDA EU representative : MDSS GmbH (Germany)	United States	OSOM® Mono Test 14598/79 OSOM® RSV/Adeno Test 197E98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen Chenghui Medical Technology EU representative : HUMISS TRADING S. L. (Spain)	China	Malaria Pathogen Nucleic Acid Detection Kit 1.198/79 Malaria Pathogen Nucleic Acid Detection Kit 2.198/79	– 98/79	EUDAMED record Report an error
Triplex International Biosciences (China) EU representative : Lotus NL B.V. (Netherlands)	China	25 tests/ kit98/79 Dengue NS1 antigen Rapid Test Kit98/79	– 98/79	Website info@tibchina.com EUDAMED record Report an error
Acmexbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Acmex Cassette14 refs98/79	– 98/79	info@acmexbio.com EUDAMED record Report an error
Aidian FDA	Finland	QuikRead go Strep A98/79	– 98/79	Website eudamed@aidian.eu EUDAMED record Report an error
Bioeuropegmbh	Germany	Fortel Ulcer (H. pylori) Screening Test 1005-198/79	– 98/79	Website info@bioeuropegmbh.com EUDAMED record Report an error
Biokit FDA	Spain	monogen kit 150 tests2 refs	B IVDR	EUDAMED record Report an error
Campmedica	Romania	See Now98/79	– 98/79	Website EUDAMED record Report an error
Coyotebio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	FlashDetect98/79	– 98/79	sales@coyotebio.com EUDAMED record Report an error
Diesse FDA	Italy	RPR-DAT TREPONEMADAT	C IVDR	Website EUDAMED record Report an error
Farmasino EU representative : Humiss International B.V. (Netherlands)	China	Dengue Rapid Test Kit (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Fortress Diagnostics	Northern Ireland	H.Pylori Device (WB/S/P) HPYC004098/79	– 98/79	Website info@fortressdiagnostics.com EUDAMED record Report an error
Giesse Diagnostics	Italy	Mononucleosi Infettiva 774698/79	– 98/79	Website info@giessediagnostics.com EUDAMED record Report an error
Gold Probe Diagnostic Biotechnology Mf EU representative : Lotus NL B.V. (Netherlands)	China	Real time RT-PCR Kit for SARS-2 Flu A Flu B98/79	– 98/79	EUDAMED record Report an error
Goldsite EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Monkeypox Virus Real-time PCR Kit3 refs98/79	– 98/79	Website export@goldsite.com.cn EUDAMED record Report an error
Hangzhou Higene Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	FLU A+B Antigen combo Rapid Test98/79	– 98/79	EUDAMED record Report an error
Hangzhou Zhunxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	HA-01298/79	– 98/79	EUDAMED record Report an error
Hotgen FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Dengue IgM/IgG Rapid test (Colloidal Gold) Please see the IFU2 refs	B IVDR	service@hotgen.com.cn EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx Influenza A&B qPCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Monlab	Spain	H. pylori Ag MonlabTest MO-804001 25 tests98/79	– 98/79	Website EUDAMED record Report an error
Newscen EU representative : Wellkang Ltd (Northern Ireland)	China	HIV3-292040170003 refs	D IVDR	Website EUDAMED record Report an error
Precision Biosensor FDA EU representative : mdi Europa GmbH (Germany)	South Korea	Exdia Strep A98/79	– 98/79	Website info@precision-bio.com EUDAMED record Report an error
Preox	Germany	preOx - HUT Helicobacter Urease Test7 refs98/79	– 98/79	Website sales@preox.de EUDAMED record Report an error
Reetoo EU representative : Umedwings Netherlands B.V. (Netherlands)	China	Influenza A&B Antigen Test kit(Colloidal Gold Immunochromatographic Assay)98/79	– 98/79	Website service@reetoo.com.cn EUDAMED record Report an error
Salofa FDA	Finland	Strep A test kit 75-75STREPA-xx98/79	– 98/79	Website info@salofa.com EUDAMED record Report an error
Sanymed	Italy	MNI - Mononucleosi (s/p/w) / Mononucleosis (s/p/w) (Qualitative) Rapid Test R1: 1x25pcs - 25 Test98/79	– 98/79	Website info@sanymed.it EUDAMED record Report an error
Screen Italia	Italy	Screen Test FLU A/B SC-0623-2098/79	– 98/79	Website info@screenitalia.it EUDAMED record Report an error
Shanghai BioGerm Medical Technology EU representative : MedNet EC-REP GmbH (Germany)	China	Influenza A/B Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Shanghai Zymetas Medtech EU representative : SUNGO Europe B.V. (Netherlands)	China	24T98/79	– 98/79	EUDAMED record Report an error
Suny (Xiamen) Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	BOIRON TEST & CARE Rapid SARS-CoV-2&Flu A&Flu B Antigen Test (Colloidal Gold)/ Nasal Swab98/79	– 98/79	EUDAMED record Report an error
Whpm FDA EU representative : Lotus NL B.V. (Netherlands)	China	Cassette WH-AT-OFLU98/79	– 98/79	customerservice@whpm.com.cn EUDAMED record Report an error
Wwhsbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Influenza A/B（Flu A/B）Antigen Rapid Test Kit（Colloidal Gold） 25Tests/Kit98/79	– 98/79	Website info@wwhsbio.com EUDAMED record Report an error
Zhongshan Bio-Tech EU representative : Lotus NL B.V. (Netherlands)	China	25 tests/kit4 refs98/79	– 98/79	EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	Chlamydia Rapid Test Device (Swab)98/79 (no longer marketed) Clostridium Difficile Toxin A+B Rapid Test98/79 (no longer marketed) Clostridium Difficile Toxin AB+GDH Rapid Test98/79 (no longer marketed) COVID-19 /Flu A&B /RSV /ADENO Ag Combo Rapid Test Cassette (Swab)98/79 (no longer marketed) COVID-19 /Flu A&B /RSV /ADENO/M.P Ag Combo Rapid Test Cassette (Swab)98/79 (no longer marketed) 16 others COVID-19 /Flu A&B /RSV Ag Combo Rapid Test Cassette (Swab)98/79 (no longer marketed) COVID-19 AG & INFLUENZA A/B COMBO RAPID TEST98/79 (no longer marketed) COVID-19 Antigen Rapid Test98/79 (no longer marketed) COVID-19 IgG IgM Rapid Test Kit98/79 (no longer marketed) Dengue IgM/IgG Rapid Test98/79 (no longer marketed) Dengue NS1 Rapid Test98/79 (no longer marketed) H. pylori Antibody Rapid Test98/79 (no longer marketed) H.pylori Antigen Rapid Test98/79 (no longer marketed) Influenza A/B Ag Rapid Test98/79 (no longer marketed) Malaria pf/pan One Step Rapid Test98/79 (no longer marketed) Malaria pf/pv One Step Rapid Test98/79 (no longer marketed) Monkeypox Antibody Rapid Test (Whole blood/Serum/Plasma)98/79 (no longer marketed) Monkeypox Antigen Rapid Test98/79 (no longer marketed) Strep A Rapid Test98/79 (no longer marketed) TORCH Rapid Test98/79 (no longer marketed) Treponema Pallidum Antibody Rapid Test98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other No model still on the market	China	100 tests/kit98/79 (no longer marketed) 25 tests/kit98/79 (no longer marketed) 50 tests/kit98/79 (no longer marketed) COVID-19 Ag Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) COVID-19 Neutralizing Antibody( COVID-19 NAb) Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) 6 others COVID-19 Neutralizing Antibody( COVID-19 NAb) Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) Freeze-dried：100 tests/kit98/79 (no longer marketed) Freeze-dried：25 tests/kit98/79 (no longer marketed) Freeze-dried：50 tests/kit98/79 (no longer marketed) Influenza A/B Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) Influenza A/B Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Nantong EgensBiotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) and 1 other No model still on the market	China	Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold) MA-Pf/Pv strip cassette98/79 (no longer marketed) Diagnostic Kit for P.falciparum Antigen （Colloidal Gold) MA-Pf strip cassette98/79 (no longer marketed) Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold) MA-Pan/Pf strip cassette98/79 (no longer marketed) Influenza A/Influenza B (FluA+B) Antigens Rapid Test Kit Flu Cassette98/79 (no longer marketed)	– 98/79	qa@egens-bio.cn EUDAMED record Report an error
Princeton BioMeditech FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) No model still on the market	United States	Status COVID-19/Flu98/79 (no longer marketed)	– 98/79	Website info@pbmc.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 24

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Alere Scarborough, Inc.	United States	BinaxNOW RSV BinaxNOW Nasopharyngeal Swab Accessory Kit BinaxNOW RSV Control Swab Kit	registered
Quidel Corp.	United States	QuickVue Sofia	K162911 (2017)
AMERICAN BIO MEDICA CORPORATION	–	RDS Easy Lab Pro RSV	registered
BTNX Inc	–	Rapid Response	registered
Becton, Dickinson & CO Present in Europe in other categories	United States	BD Veritor™ System For Rapid Detection of RSV - CLIA waived kit BD Veritor™ System For Rapid Detection of RSV - Laboratory kit	K133140 (2013)
MCKESSON MEDICAL-SURGICAL INC.	–	McKesson	registered
Response Biomedical Corp. Present in Europe in other categories	Canada	RAMP® RSV TEST KIT; 25 TESTS RAMP® RSV Control Swabs	K091235 (2009)
Meridian Bioscience, Inc. Present in Europe in other categories	United States	TRU RSV	K041445 (2004)
NANO-DITECH CORPORATION	United States	Nano-Check RSV Test	K240280 (2024)
Oxoid U.S.A., Inc. Present in Europe in other categories	United States	IMAGEN Respiratory Syncytial Virus (RSV)	registered
Rodimedi & Associates, Inc.	–	Red Tunica	registered
BioSquare Inc.	South Korea	–	registered
Boditech Med Inc. Present in Europe in other categories	South Korea	–	registered
CBR Enterprise Limited	Hong Kong SAR China	–	registered
Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd	China	–	registered
NOVEM MEDICAL S. DE R.L. DE C.V.	Mexico	–	registered
Panion & BF Biotech, Inc.	Taiwan	–	registered
Planet Innovation Products, Inc.	United States	–	registered
QuidelOrtho Corporation	United States	–	registered
STS Corporation	United States	–	registered
Sa Scientific, Inc.	United States	–	K022845 (2003)
Sanicure BV	Netherlands	–	registered
Scantibodies Laboratory Inc.	United States	–	registered
Via systems Manufacturas	Mexico	–	registered

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