ReagentsInfectious diseasesInfectious immunology - rapid tests & point of care

Multiple pathogens - RT & POC

EMDN code W01050906

74 manufacturers, 795 models including 789 on the market, 11 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 74

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 Cassette98/79 134 others 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 Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 CARBA-5 Rapid Test98/79 Chikungumya lgG&lgM/Dengue lgG&lgM/Dengue NS1 Combo Rapid Test98/79 Chikungunya/Zika Combo Rapid Test ICZ-42598/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test98/79 Dengue NS1 and Zika NS1 Combo Rapid Test98/79 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 HAV IgG/IgM&Syphilis Combo Rapid Test IHAS-43598/79 HAV IgM&Syphilis Combo Rapid Test IHAS-42598/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette98/79 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+H5N1 Antigen Combo Rapid Test98/79 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 Norovirus+Rotavirus+Adenovirus+Astrovirus Combo Rapid Test IMVD-R64598/79 Norovirus+Rotavirus/Adenovirus+Astrovirus+Enterovirus Combo Rapid Test IMVD-65598/79 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 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 Rotavirus Group A and Norovirus GI/GII RT-qPCR Kit2 refs98/79 Rotavirus/Adenovirus+Astrovirus Combo Rapid Test IRAA-62598/79 RSV &Influenza A+B Combo Rapid Test Cassette IRIC-R52598/79 RSV and SARS-CoV-2 Antigen Combo Rapid Test98/79 RSV&Influenza A+B Combo Rapid Test Cassette IRIC-52598/79 RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 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/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/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 Trichomonas vaginalis/Gardnerella vaginalis/Candida albicans Combo Rapid Test98/79 TropiDetect Triple Test98/79	– 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 pneumoniae/RSV/Influenza A+B Combo Test Cassette acrARF535F98/79 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 61 others 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 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 Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Chikungunya and Dengue Combo Rapid Test acrCKDE43598/79 Chikungunya/Zika Combo Rapid Test ICZ-ACO42598/79 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 Dengue NS1 and Zika NS1 Combo Rapid Test98/79 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 HAV IgG/IgM&Syphilis Combo Rapid Test IHAS-ACO43598/79 HAV IgM&Syphilis Combo Rapid Test IHAS-ACO42598/79 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 Multiplex Respiratory Antigen Rapid Test (Swab) acrRTC595R98/79 Mycoplasma pneumoniae/Adenovirus pneumoniae/ RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Cassette98/79 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/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 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/Adenovirus+Astrovirus Combo Rapid Test IRAA-ACO62598/79 RSV and SARS-CoV-2 Antigen Combo Rapid Test98/79 RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test2 refs98/79 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 Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test2 refs98/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Vitrosens	Türkiye	RapidFor™12 refs RapidFor™ CT + NG v2.0 Test Kit 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 50 others 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 Kit3 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™ VMD101BC98/79 RapidFor™ VMD101FD98/79 RapidFor™ VMD109STS RapidFor™ VMD112FD98/79 RapidFor™ VMD135FD98/79 RapidFor™ VMD141SC98/79 RapidFor™ VMD146BC98/79 RapidFor™ VMD146TD98/79 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™ VMD175FD98/79 RapidFor™ VMD176STS98/79 RapidFor™ VMD187FD98/79 RapidFor™ VMD188SC98/79 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™ VSCD08ST0198/79 WellFor VSCD10ST0198/79	B, C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	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 33 others 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 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 / 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/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	– 98/79	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 32 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 COVID-19 Ag/Influenza A+B Combo FIA Test98/79 Dengue/Chikungunya/Zika Combo Test BSP35-DCZ98/79 Dengue/Zika/Chikungunya Combo Test BSP45-DZC98/79 HSV 1/2 IgG Test2 refs98/79 HSV 1/2 IgG/IgM Test4 refs98/79 HSV 1/2 IgM Test2 refs98/79 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&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/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	– 98/79	info@acesolab.com EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain)	China	Adenovirus pneumoniae and RSV Combo Assay F11-AR01C598/79 Adenovirus&RSV Combo Rapid Test L11-AR02C598/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test L11-ARI03C598/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 HSV 1/2 IgG Rapid Test2 refs98/79 29 others HSV 1/2 IgG/IgM Rapid Test4 refs98/79 HSV 1/2 IgM Rapid Test2 refs98/79 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 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 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 Norovirus, Rotavirus and Adenovirus Combo Test98/79 One Step SARS-CoV-2 and M.pneumoniae IgG Combo Test98/79 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 RSV&Influenza A+B Combo Rapid Test L11-RI02C598/79 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 M.pneumoniae IgG/IgM Combo Rapid Test98/79 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	– 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 pneumoniae and RSV Combo Test Device- Nasopharyngeal Swab D-FIARNSD2098/79 Adenovirus pneumoniae/RSV/Influenza A+B Combo Test Device-Nasopharyngeal Swab D-FIARID2098/79 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/RSV/HMPV/Influenza A+B Combo Rapid Test Device-Swab98/79 23 others Adenovirus/RSV/HMPV/Influenza A+B/COVID-19 Combo Rapid Test Device-Swab98/79 COVID-19 Ag/Influenza A+B Combo Test Device – Nasopharyngeal Swab98/79 Dengue/Zika/Chikungunya Combo Rapid Test Device-WB/S/P98/79 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 Mycoplasma pneumoniae/Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Device-Nasopharyngeal Swab98/79 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 Rotavirus and Adenovirus Test Device-Feces D-FIROAAGD1098/79 Rotavirus and Adenovirus Test Device-Feces D-FIROAAGD2598/79 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/COVID-19 Combo Test Device-Nasopharyngeal Swab98/79 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/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	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Tongzhoubio FDA EU representative : VidaQuick Biotech S.L. (Spain)	China	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 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Chikungunya and Dengue Combo Rapid Test I202-403598/79 21 others 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 Multiplex Respiratory Virus Antigen Rapid Test I161-507598/79 Multiplex Respiratory Virus Antigen Rapid Test I161-5XX598/79 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 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/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	– 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 Dengue/Chikungunya/Zika Combo Test DCZ-4C398/79 Dengue/Zika/Chikungunya Combo Test DZC-4C498/79 17 others HSV 1/2 IgG Test2 refs98/79 HSV 1/2 IgG/IgM Test4 refs98/79 HSV 1/2 IgM Test2 refs98/79 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&Flu A+B Combo 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/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	– 98/79	info@bitrumed.com.cn 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 16 others 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 HSV 1/2 IgG/IgM Rapid Test Cassette2 refs98/79 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&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/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	– 98/79	info@actest.com.cn EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany)	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 14 others 8-in-1 Respiratory Antigen Combo Rapid Test RVC-585b-25M 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 Norovirus/Rotavirus/Adenovirus Antigen Combo Rapid Test GIC-635a98/79 Respiratory Multiple Antigen Combo Test RVC-5X598/79 Rotavirus/Adenovirus Combo Rapid Test RAC-622a98/79 RVC-5105a98/79 RVC-535b RVC-585c98/79	B 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 Virus IgG/IgM/NS1 & Chikungunya Virus IgM/IgG Combo Rapid Test Kit98/79 13 others 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 Influenza A/B & RSV & Adenovirus & hMPV & PIV & M. pneumoniae Ag Combo Rapid Test Kit98/79 Influenza A/B, SARS-CoV-2, RSV, Adenovirus, Measles Virus, Mumps Virus and HPIV Antigen Combo Rapid Test Kit98/79 Rotavirus / Adenovirus / Norovirus (GI/GII) Ag Combo Rapid Test Kit98/79 RSV & ADV 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 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
Safecare FDA EU representative : Medunion S.L. (Spain) and 4 others	China	Bacterial Vaginosis Multi-Test Kit98/79 Bacterial Vaginosis Multi-Test(Swab)98/79 COVID-19 & Influenza A+B Antigen Combo Rapid Test98/79 COVID-19/Flu/RSV/ADV/hMPV Antigen Combo Rapid Test98/79 COVID-19/Flu/RSV/ADV/hMPV/HPIV Antigen Combo Rapid Test98/79 13 others 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 Kit de prueba de antígenos de múltiples virus respiratorios ( Hisopo ) (Gripe A+B/ COVID-19)98/79 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 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
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 COVID-19 A/B- RSV- ADENO ÇOKLU HIZLI TEST KİTİ 13 others 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 FLU A/B-RSV RAPID TEST KIT INFLUENZA A/B RSV RAPID TEST KIT VISD073 İNFLUENZA A-B/RSV/ADENO HIZLI TEST KİTİ 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 STREPTOCOCCUS PNEUMONIAE-LEGIONELLA PNEUMOPHILA HIZLI TEST KİTİ TORCH IgG-IgM RAPID TEST KIT White Lung Syndrome Middle Panel Rapid Test Kit VISD079	B, C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others	China	C. difficile Toxin A/B Rapid Test Format (cassette): A4A93011 A4A930125 A4A930140 A4A93021 A4A930225 A4A930240 COVID-19 & Influenza A/B & RSV & ADV & HMPV Antigen Combo Test COVID-19 & Influenza A/B & RSV Antigen Combo Rapid Test98/79 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 12 others 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 Fastep MI-S33001H598/79 FLU A/FLU B/RSV/ADV/MP/COVID-19 Combo Test98/79 Influenza A/B & RSV & ADV Antigen Combo Test Influenza A/B & RSV Antigen Combo Test A4C83011 Influenza A/B&ADV Antigen combo Test Format (cassette): A4D33011 A4D330120 A4D330140 A4D33021 A4D330220 A4D330240 Format (pen): A4D36011 A4D360120 A4D36021 A4D360220 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	B IVDR, 98/79	Website contact@diareagent.com EUDAMED record Report an error
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Candida Albicans/Gardnerella Vaginalis/Trichomonas Vaginalis Ag Rapid Test P203298/79 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 10 others 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 RSV/Radv/Flu A+B Antigen Rapid Test P209098/79 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
Hangzhou Laihe Biotech FDA EU representative : Medunion S.L. (Spain) and 1 other	China	BIOSYNEX 86079398/79 LYHER 303021901 LYHER 3030340023 refs LYHER 303034701-01;303034701-05;303034701-20;303034701-25;303034701-403 refs LYHER 3030348013 refs 10 others LYHER 3030419013 refs LYHER 303045201-01;303045201-05;303045201-20;303045201-25;303045201-403 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 Respiratory Multiple Rapid Test98/79	B IVDR, 98/79	office@lyher.com EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain)	China	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 7 others 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	– 98/79	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
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™ GASTROINTESTINAL 3-in-1 Rapid Antigen Test98/79 INDICAID™ HPV Virus Staining Test98/79 INDICAID™ Multiple Respiratory Pathogen Rapid Antigen Test98/79 INDICAID™ Respiratory 12-in-1 Rapid Antigen Test98/79 6 others 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 P0098, P009998/79	– 98/79	Website info@phasesci.com EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	RightSign2 refs98/79 Rightsign ICBAD-MC8398/79 Rightsign ICFGN-MC8398/79 Rightsign ICFR-MC8498/79 Rightsign ICFRA-MC8598/79 5 others Rightsign ICFRAM-MC8698/79 Rightsign ICFRAN-MC8598/79 Rightsign IRCF-MC8498/79 Rightsign IRCF-MC84S98/79 Rightsign IRCFN-MC8498/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	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 5 others 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 Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab) GCFCRA-545a98/79 Rapid COVID-19+Influenza Antigen Test GCFC-525a98/79 Smart Rapid COVID-19 & Flu A/B Ag Test Device GCFC-T503a98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Rapid Flu A+B/RSV Antigen Test Card98/79 Rapid Flu A+B/RSV/ADV Antigen Test Card98/79 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 4 others 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	C IVDR, 98/79	Website EUDAMED record Report an error
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş	Türkiye	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 4 others Rotavirus Adenovirus Test TRA0198/79 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	– 98/79	Website info@turklab.com.tr EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other	China	1 test/kit8 refs98/79 25 tests/kit8 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 3 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	– 98/79	info@genesignbio.com 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
Aichek FDA EU representative : Medunion S.L. (Spain) and 1 other	China	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 COVID-19/Influenza A+B/RSV/Adenovirus/MP Antigen Combo Rapid Test98/79 Rotavirus/Adenovirus Antigen Combo Rapid Test RAV-F22a98/79 1 other Salmonella typhi & Salmonellaparatyphi Antigen Combo Rapid Test98/79	– 98/79	ra.rep@aichek.com EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain)	China	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 1 other SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 5 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
Vivachek FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Multiplex Respiratory Antigen Rapid Test VIRI3 refs98/79 Mycoplasma pneumoniae Ag Rapid Test VIMPg98/79 Mycoplasma pneumoniae IgM Rapid Test VIMPb98/79 SARS-CoV-2/Flu A/Flu BAg Rapid Test VLD0198/79 SARS-CoV-2/Influenza A+B Ag Combo Rapid Test VIRI98/79 1 other SARS-CoV-2/Influenza A+B Ag Combo Rapid Test VLD01-03-1398/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Shenzhen Huian Biosci Technology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	1T/Kit6 refs98/79 20T/Kit6 refs98/79 5T/Kit6 refs98/79 REF206-00198/79 REF206-02098/79	– 98/79	info@huiantech.com EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	FIAflex SARS-CoV-2 & Influenza A/B Ag Combo FIA98/79 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	– 98/79	Website EUDAMED record Report an error
Anhui Formaster Biosci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	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	– 98/79	Website EUDAMED record Report an error
Avioq Bio-tech EU representative : SUNGO Europe B.V. (Netherlands)	China	1 Test/Kit98/79 20 Tests/Kit98/79 40 Tests/Kit98/79 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	1 test/kit5 refs98/79 25 tests/kit2 refs98/79 50 tests/kit98/79 Cassette(25 tests/kit)98/79	– 98/79	info@fanttest.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	ACAB04D-BOG48E98/79 COVID-19 & Influenza A/B Rapid Test Cassette (Swab) GCFC-525Sa98/79 COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) GCFC-T502a98/79 Smart Rapid COVID-19 & Flu A/B Ag Test Device GCFC-T503a98/79	– 98/79	EUDAMED record Report an error
Sejoy FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	ISIRA-944598/79 ISIRAH-965598/79 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	– 98/79	Website EUDAMED record Report an error
Azubio Diagnostics EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Pen A47660H11 Pen A49560H11 Pen A4D660H11	C IVDR	EUDAMED record Report an error
Biosynex EU representative : BIOSYNEX (France)	France, Switzerland	BIOSYNEX COMBO ADENO/ROTA BSS98/79 BIOSYNEX COMBO COVID-FLU BSS98/79 IMMUNOQUICK NoRotAdeno98/79	– 98/79	Website reglementaire@biosynex.com EUDAMED record Report an error
InTec PRODUCTS EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	AQ+Rapid SARS-CoV-19/ Flu Combo Test ITP160503 refs98/79 COVID-19/FluA&B/RSV Ag Combo Rapid Test ITP18260398/79 Rapid Rota-Adenovirus Combo Test ITP1400398/79	– 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
nal von minden	Germany	NADAL® Legionella /S. pneumoniae Test98/79 NADAL® Norovirus GI/GII+Rota-Adenovirus Test98/79 NADAL® Rota-Adenovirus Test98/79	– 98/79	Website info@nal-vonminden.com 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 Rota/Adenovirus Combo Rapid Test LATG03-C2598/79	– 98/79	EUDAMED record Report an error
Zetmedikal	Türkiye	SARS-CoV-2 IgG/IgM Rapid Antibody Test98/79 SOFTEC SARS-CoV-2 Antigen Rapid Test (Nasal Swab)98/79 SOFTEC SARS-CoV-2 Neutralizing Antibody Rapid Test98/79	– 98/79	Website info@zetmedikal.com EUDAMED record Report an error
Aaz Productions Le Materiel Biomedical	France	ALL IN QUADRIPLEX®98/79 COV-GRIP98/79	– 98/79	EUDAMED record Report an error
Association Of Medicine Analytics EU representative : CMC Medical Devices & Drugs SL (Spain)	Russia	AMA DENT98/79 AMA VENERA98/79	– 98/79	Website EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	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	– 98/79	EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruVue98/79 TruVue COVID-19& Influenza A +B Antigen Combo Rapid Test (LFA)98/79	– 98/79	EUDAMED record Report an error
Certest	Spain	CerTest SARS-CoV-2+ Flu A + Flu B3 refs CerTest SARS-CoV-2+ Flu A + Flu B + RSV3 refs	B IVDR	Website quality@certest.es 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
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
Dynamiker EU representative : Lotus NL B.V. (Netherlands)	China	20 tests98/79 20 tests (A)98/79	– 98/79	Website marketing@dynamiker.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	C IVDR, 98/79	Website info@medomics-dx.com EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland)	China	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	– 98/79	Website sales@limingbio.com EUDAMED record Report an error
Neo-nostics (Suzhou) Bioengineering EU representative : Medunion S.L. (Spain)	China	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
Operon FDA	Spain	Simple AG SARS-CoV-2 / Flu A+B 9.242.XXX.YY.ZZZ3 refs Simple RSV-Flu A+B 9.081.XXX.YY.ZZZ3 refs	B IVDR, 98/79	Website infoeudamed@operon.es EUDAMED record Report an error
Shenzhen Lvshiyuan Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Flu A & Flu B & COVID-19 Ag Rapid Test Flu A & Flu B & RSV & COVID-19 Ag Rapid Test Kit (Colloidal Gold) HM003A3	B IVDR	Website EUDAMED record Report an error
Acmexbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	ACMEX Cassette6 refs98/79	– 98/79	info@acmexbio.com EUDAMED record Report an error
Citest Diagnostics EU representative : VidaQuick Biotech S.L. (Spain)	Canada	Mycoplasma pneumoniae IgM Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	ra02@citestdiagnostics.com EUDAMED record Report an error
Hecin EU representative : Share info GmbH (Germany)	China	COVID-19/Flu A&B Rapid Antigen Test3 refs	B IVDR	EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Flu A+B/MP Antigen Rapid Test98/79	– 98/79	Website 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	– 98/79	EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	Influ A+B/ADV/RSV Ag 4-in-1 Test Panel98/79	– 98/79	EUDAMED record Report an error
Labnovation EU representative : MedNet EC-REP GmbH (Germany)	China	SARS-CoV-2 Antigen and Influenza A/B Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	Website info@labnovation.com EUDAMED record Report an error
Ortho-Clinical Diagnostics Summers Ridge San Diego EU representative : MDSS GmbH (Germany)	United States	Sofia 2 Flu + SARS Antigen FIA98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Sekisui Diagnostics FDA EU representative : MDSS GmbH (Germany)	United States	OSOM® RSV/Adeno Test 197E98/79	– 98/79	Website 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
Vazyme EU representative : Obelis s.a. (Belgium)	China	SARS-CoV-2 and Influenza A/B Virus Antigen Combined Detection Kit (Colloidal Gold-Based)98/79	– 98/79	EUDAMED record Report an error
Wizbiotech EU representative : QbD RepS BV (Belgium)	China	Diagnostic Kit for Antigen to Rotavirus/Adenoviruses (Latex)98/79	– 98/79	EUDAMED record Report an error
Xenta Biomedical Science FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	IFA & IFB & COVID-19 Antigen Joint Detection Kit (Immunochromatography Assay)2 refs98/79	– 98/79	Website EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands)	China	Rota/Adeno Ag Rapid Test GIRA98/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI Device:20 Test/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	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) 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) TORCH Rapid Test98/79 (no longer marketed)	– 98/79	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

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