ReagentsInfectious diseasesInfectious immunology - rapid tests & point of care

Bacteriology - RT & POC

EMDN code W01050901

114 manufacturers, 879 models including 871 on the market, 23 countries

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

Manufacturers registered in Europe (EUDAMED) 114

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	berkeleyhealth Easy Check Strep A rapid test (Professional)98/79 Berkeleyhealth Easy Check Strep A rapid test cassette98/79 Casete de Prueba Rápida de Legionella pneumophila98/79 Cassette Test Rapide Strep A98/79 Chlamydia Rapid Test Cassette ICH-50298/79 88 others 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+ 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 Family Health Self Test Helicobacter Pylori IHP-N602H-013 refs Gesunder Magen2 refs98/79 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 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 Magsår H. Pylori98/79 Mivolis H. pylori Antigen Rapid Test Cassette98/79 Mivolis Schnelltest Gesunder Magen2 refs98/79 Prueba Rápida de antígeno de H. Pylori en casete98/79 Prueba Rápida de S. pneumoniae Antígeno en Casete98/79 RPR Reagents5 refs98/79 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 Antigen Rapid Test Cassette (Urine) ISP-10298/79 Schnelltest Gesunder Magen98/79 SCREEN® Strep A Test3 refs 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 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 TPHA Reagents3 refs98/79 ZuhauseTEST Gesunder Magen2 refs98/79	B, C IVDR, 98/79	info@alltests.com.cn EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	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 44 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 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 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
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş	Türkiye	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 35 others 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 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 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
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	United States	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 26 others 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 Combo Test Cassette (Feces) ACO-CDT-62598/79 Legionella Pneumophila Rapid Test Cassette (Urine)98/79 RPR Reagents5 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 Test Cassette (Urine)98/79 Streptococcuspneumoniae Antigen Rapid Test Cassette98/79 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 TPHA Reagents3 refs98/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
nal von minden	Germany	dedicio® Strep A Test3 refs98/79 FUTURLAB® Strep A Test98/79 Hitado strep a2 refs98/79 Hitado strep a Test3 refs meditrol® Strep A Test98/79 25 others 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® H.pylori Ag Test2 refs98/79 NADAL® H.pylori Ab Test2 refs98/79 NADAL® Legionella Test2 refs98/79 NADAL® RPR Carbon 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
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain)	United States	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 19 others 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 Legionella pneumophila FIA Test98/79 Legionella pneumophila 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
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 R102-11098/79 R102-11298/79 19 others R102-11498/79 R108-11098/79 R108-11298/79 R109-11298/79 R16-11098/79 R16-11298/79 R18-11098/79 R18-11298/79 R18-11698/79 R19-11098/79 R19-11298/79 R200-11298/79 R34-11098/79 R34-11298/79 R66-11098/79 R66-1122 refs98/79 R92-11098/79 R92-11298/79 R92-11698/79	– 98/79	EUDAMED record Report an error
Bitrumed EU representative : VidaQuick Biotech S.L. (Spain)	China	Clostridium difficile GDH & Toxin A &Toxin B Combo Test CD-6C398/79 Clostridium difficile GDH & Toxin A &Toxin B Combo Test CD-6F398/79 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 18 others Clostridium difficile Toxin A &Toxin B Combo Test CDT-6C298/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette ICDT-625B98/79 Legionella pneumophila Rapid Test Cassette98/79 Legionella pneumophila Test98/79 S. pneumoniae Antigen Rapid Test Cassette ISP-10298/79 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
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	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 H. pylori Ab Rapid Test Cassette (Serum/Plasma) GCHP-302a98/79 H. pylori Ab Rapid Test Cassette (Whole blood/Serum/Plasma) GCHP-402a98/79 17 others 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 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
Abbott FDA EU representative : Emergo Europe B.V. (Netherlands) and 2 others	Japan, South Korea, United States	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™ H.pylori 04FK1098/79 16 others Bioline™ H.pylori 04FK1198/79 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 Determine98/79 Determine Syphilis TP 30T 7D244298/79 ID NOW™ Strep A 2 (24T) 734-00098/79 SD BIOLINE H.pylori 04FK1098/79 SD BIOLINE H.pylori 04FK1198/79 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
Rapid Labs EU representative : Advena Limited (Malta) and 1 other	United Kingdom (ex Northern Ireland)	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 Combo Test Device-Feces D-FICDTABD1098/79 16 others Clostridium difficile Toxin A/Toxin B Combo Test Device-Feces D-FICDTABD2598/79 Legionella pneumophila Test Device -Urine2 refs98/79 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 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 Test Device -Urine2 refs98/79 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	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain)	China	Clostridium difficile GDH Assay F11-CDG01C698/79 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/B Assay F11-CD01C698/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test L11-CDT02C698/79 15 others Clostridium difficile Toxin A/ toxin B Combo Assay F11-CDT01C698/79 Clostridium difficile Toxin A/Toxin B Combo Assay F11-CDT02C698/79 Legionella pneumophila Assay98/79 Legionella pneumophila Rapid Test98/79 One Step Syphilis Test98/79 One Step Clostridium difficile GDH+ Toxin A +Toxin B Combo Test98/79 Strep A Assay F11-STA01C598/79 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 Rapid Test L11-SB01A598/79 Streptococcus pneumoniae Antigen Rapid Test98/79 Streptococcus pneumoniae Assay98/79 Syphilis Assay F11-SYP01C498/79	– 98/79	Website info@kylinew.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 H. pylori Ab Rapid Test VIHP2 refs98/79 H. pylori Ag Rapid Test VIHP98/79 H. pylori Ag Rapid Test VIHP-40198/79 14 others H. pylori Antibody Test Kit (FIA) VID8298/79 H. pylori Antigen Test Kit ( FIA) VID8398/79 Legionella Pneumophila Rapid Test VILEG-10198/79 Quick MASTER Strep A Test Kit (FIA) VID1072 refs98/79 S.pneumoniae Rapid Test VISP98/79 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
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® H. pylori Antigen Cassette (Feces)98/79 Accu-Tell® H. pylori IgG Cassette(Serum/Plasma)98/79 11 others 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® Legionella Pneumophila Antigen Cassette (Urine)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	– 98/79	sales@accubiotech.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	C. difficile GDH FIA GDH-F23F398/79 Device A40110120 Device A41511125 Device A45910120 H. pylori Antibodies Rapid Test HP-P11, HP-P23, HP-W11, HP-W2398/79 11 others H. pylori Antibodies Rapid Test HP-W2398/79 H. pylori Antibody FIA HP-W23F398/79 H. pylori Antigen FIA HP-F23F398/79 Legionella Antigen Rapid Test Device (Urine) LEG-U2398/79 Mycoplasma Pneumoniae Antigen Rapid Test Device A46710120,A46710220 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
Vitrosens	Türkiye	RapidFor™16 refs RapidFor™ H.pylori Ag Rapid Test Kit (FIA) VMPO6798/79 RapidFor™ H.Pylori v2.0 Test Kit RapidFor™ VMD04BD98/79 RapidFor™ VMD04BD50LA98/79 11 others RapidFor™ VMD110D98/79 RapidFor™ VMD150FD98/79 RapidFor™ VMD150SC98/79 RapidFor™ VMD16TD98/79 RapidFor™ VMD16TD0198/79 RapidFor™ VMD36DTS98/79 RapidFor™ VMD36STS98/79 RapidFor™ VMPO126ED98/79 RapidFor™ VMPO126UP98/79 RapidFor™ VMPO67GD98/79 WellFor Strep A v2.0 Test Kit VMD150ST0198/79	B, C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Safecare FDA EU representative : UnicareQ GmbH (Germany) and 1 other	China	"H.pylori Antibodies Rapid Test Kit (Whole Blood/serum/plasma)" HPAb-4011/HPAb-401298/79 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 10 others H.pylori Antigen Rapid Test Kit(Feces) HPAg-5011/HPAg-501298/79 Rotavirus Antigen Rapid Test(Feces) ROT-5011/ROT-501298/79 Rotavirus Rapid Test (Feces) ROT-5011/ROT-501298/79 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	– 98/79	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 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 9 others Legionella Pneumophila Rapid Test GILeg98/79 Legionella Rapid Test GILeg98/79 S.pneumoniae Rapid Test GISPNE98/79 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
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 8 others H.pylori Antigen Rapid Test Cassette (Feces) IHP-60298/79 H.pylori Antigen Rapid Test Cassette (Feces) IHP-602(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
Tongzhoubio FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Clostridium Difficile GDH Test Kit YI062-600298/79 Clostridium difficile Toxin A/ toxin B Combo Test Kit YI010-602598/79 H.Pylori Antibody Rapid Test I021-N4002-253 refs Legionella pneumophila Rapid Test98/79 Legionella pneumophila Test Kit98/79 8 others 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	B IVDR, 98/79	EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain)	China	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 Legionella pneumophila Rapid Test Cassette98/79 7 others 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
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 IHP-30298/79 6 others IHP-40298/79 IHP-60298/79 IST-50198/79 IST-50298/79 ISY-U40198/79 ISY-U40298/79	– 98/79	EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	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 6 others 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 IVDR, 98/79	EUDAMED record Report an error
Biosynex EU representative : BIOSYNEX (France)	France, Switzerland	BIOSYNEX C. difficile GDH BIOSYNEX Legionella pneumophila BSS98/79 BIOSYNEX Legionella pneumophila BSX98/79 BIOSYNEX S.pneumoniae98/79 BIOSYNEX S.pneumoniae BSX98/79 6 others BIOSYNEX Strep A98/79 BIOSYNEX Strep A BSX98/79 CHLAMYTOP98/79 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
Biotical	Spain	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 biotical C. difficile GDH Card / 25 test rápidos con viales para muestra fecal (sin controles externos).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 5 others biotical C. difficile Toxins A + B Card / 25 test rápidos con viales para muestra fecal (sin controles externos).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 (30u) / 30 controles positivos H. pylori (sin test rápido)98/79	– 98/79	Website EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : Medunion S.L. (Spain) and 1 other	China	Chlamydia Antigen Rapid Test Kit Cassette ICH-502 LYHER ISA-502-0198/79 LYHER ISA-502-0298/79 LYHER ISA-502-0598/79 LYHER ISA-502-0798/79 5 others 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	C IVDR, 98/79	office@lyher.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	C. DIFFICILE TOXIN A/TOXIN B/GDH RAPID TEST KIT VISD075 C. DIFFICILE/ GDH HIZLI TEST KİTİ CHLAMYDIA RAPID TEST KIT VISD029 Clostridium Difficile Toxin A+B Rapid Test VISD125 H.PYLORI AB RAPID TEST VISD013 5 others H.PYLORI AG RAPID TEST VISD012 SOLUNUM YOLU PATOJENLERİ TARAMA 24 PARÇALI KİTİ RESPIRATORY PATHOGENS SCREENING 24P KIT STREP A RAPID TEST KIT VISD024 Streptococcus Pneumoniae Hızlı Test Kiti TOXIN A/B RAPID TEST KIT VISD034	B, C IVDR	Website info@visionbiotechnology.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
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands)	China	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 Legionella Urinary Antigen Test Card 1O05C398/79 Rapid Strep A Test Card 1O08C598/79 3 others Rapid Strep A Test Card 1O08C5-198/79 Rapid Syphilis Antibody Test Card 1N02C298/79 Rapid Syphilis Antibody Test Strip 1N02S298/79	– 98/79	Website 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
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 DIAGOTEC Strep A Rapid Test3 refs Group B Streptococcus (GBS) Ag Rapid Test P202798/79 3 others H. pylori (HP) Ag Rapid Test P202098/79 H.pylori Ab (HP Ab) Rapid Test P202198/79 Sinocare Strep A FIA KIT98/79	C IVDR, 98/79	Website info@gensurebio.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 GDH / STICK GDH 9.045.XXX.YY.ZZZ3 refs Simple GDH-Toxins 9.065.XXX.YY.ZZZ3 refs Simple H.pyl / Stick H.pyl 9.076.XXX.YY.ZZZ98/79 3 others SIMPLE Legio pneumo / STICK Legio pneumo 9.106.XXX.YY.ZZZ98/79 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
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI Device:20 Test/Kit98/79 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/Kit98/79 Strep A Rapid Test Device IST-502s	C IVDR, 98/79	EUDAMED record Report an error
Association Of Medicine Analytics EU representative : CMC Medical Devices & Drugs SL (Spain)	Russia	AMA RUT Expert98/79 AMA RUT Pro (48 in blocks)98/79 AMA RUT Pro (block of 24)98/79 HELIC ABT Reader indicator tube kit (1 pcs)98/79 HELIC ABT Reader indicator tube kit (30 pcs)98/79 1 other HELIC ABT Reader indicator tube kit (50 pcs)98/79	– 98/79	Website 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/kit98/79 100 tests/kit98/79 20 tests/kit98/79 5 tests/kit98/79 1 other 50 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 H. pylori Ab - kasetki 20 szt. H. pylori Ag w kale - kasetki 20 szt. RPR Carbon (+kontrola / +control) RPR Carbon bez kontroli 100 ozn.2 refs 1 other Syfilis / Syphilis Syfilis kasetki 40 szt.2 refs	B, C IVDR	Website info@biomaxima.com 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 Legionella 1 other CerTest S. pneumoniae	B, C IVDR	Website quality@certest.es EUDAMED record Report an error
Clongene FDA EU representative : HUMISS TRADING S. L. (Spain) and 1 other	China	H.pylori Antibody Rapid Tests IHPB4001, IHPB400298/79 H.pylori Antigen Rapid Test Cassette (Feces) IrHPG600298/79 Legionella pneumophila Antigen Rapid Test ILP100298/79 Streptococcus pneumoniae Antigen Rapid Test ISP100298/79 Strep A Rapid Tests ISAp001 ISAp002 ISAp00898/79 1 other Syphilis Rapid Tests ITP4001, ITP400298/79	– 98/79	Website marketing@clongene.com EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Ferrarihub98/79 RightSign6 refs RightSign Home+ Rightsign IHPB-S4198/79 Rightsign IHPC-MC3298/79 1 other Rightsign ILP-C1198/79	B, C IVDR, 98/79	info@biotests.com.cn 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 H.Pylori Ab Test Kit Ir03098/79 H.Pylori Ag Test Kit Ir03198/79 Mycoplasma Pneumoniae Ab Test Kit Ir04798/79 1 other Strep A Ag Test Kit Ir04498/79	– 98/79	EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany)	China	H. pylori Antigen Rapid Test HP-602a98/79 H. pylori Antibody Rapid Test HP-402b98/79 Medotex H. pylori Antigen Rapid Test HP-602a Medotex H. pylori Antibody Rapid Test HP-402b Syphilis Rapid Test SYP-401a 1 other Syphilis Rapid Test SYP-402b98/79	B, C IVDR, 98/79	Website EUDAMED record Report an error
Wizbiotech EU representative : QbD RepS BV (Belgium)	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 1 other Diagnostic Kit for Antibody to Treponema Pallidum(Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Aichek FDA EU representative : Medunion S.L. (Spain) and 1 other	China	H. Pylori Antibody Rapid Test HP-D02a, HP-D01a98/79 H. Pylori Antigen Rapid Test HP-F02a98/79 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
Artronlab FDA EU representative : MedNet EC-REP GmbH (Germany)	Canada	Acmex Treponema Pallidum (TP) Antibody Test Cassette2 refs Artron Helicobacter Pylori (HP) Antibody Test cassette98/79 Artron Helicobacter pylori (HP) Antigen 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 IVDR, 98/79	Website info@artronlab.com 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
Phasescientific FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Hong Kong SAR China	INDICAID™ Helicobacter pylori Rapid Antigen Test98/79 INDICAID™ Helicobacter pylori Rapid IgG Antibody Test98/79 INDICAID™ Strep A Rapid Antigen Test98/79 INDICAID™Strep B Rapid Antigen Test98/79 INDICAID™Treponema Pallidum Rapid Antibody Test98/79	– 98/79	Website info@phasesci.com EUDAMED record Report an error
Vircell	Spain	VIRAPID® CLOSTRIDIUM DIFFICILE (GDH) Ag VRC004 VIRAPID® CLOSTRIDIUM DIFFICILE (GDH/TOX A/TOX B) Ag VRC005 VIRAPID® LEGIONELLA CULTURE VR00298/79 VIRAPID® LEGIONELLA PNEUMOPHILA Ag FIA VRF002 VIRAPID® STREPTOCOCCUS GROUP A Ag VRC003	B, C IVDR, 98/79	EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Medunion S.L. (Spain) and 1 other	China	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 Strep A Antigen Test Kit Cassette GAS1TST-13 refs	C IVDR, 98/79	sales@dbluemedical.com EUDAMED record Report an error
Anhui Formaster Biosci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	H. pylori Antigen Rapid Test (Feces) IHP-301398/79 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
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	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	– 98/79	EUDAMED record Report an error
Chemtronbio EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others	China	Cassette 8022C98/79 Chlamydia Trachomatis Rapid Test 8001C01P25 Chlamydia Trachomatis Rapid Test Cassette 8001C98/79 HP Ag H.pylori Antigen Rapid Test	B, C IVDR, 98/79	Website EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany)	China	Group B Streptococcus Rapid Test Kit98/79 H.Pylori Ag Rapid Test Kit GKPD12998/79 Legionella pneumophila Ag Rapid Test Kit98/79 Streptococcus pneumoniae Ag Rapid Test Kit98/79	– 98/79	office@guoke-medical.com EUDAMED record Report an error
Dutch Diagnostics	Netherlands	H.Pylori Ab Test2 refs98/79 H.Pylori Ag Test98/79 Strep A Test3 refs98/79 TMS Strep A2 refs98/79	– 98/79	Website info@dutch-diagnostics.com EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	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 Rapid Test Cassette (Feces) GCHP-602a98/79 Syphilis Ab Rapid Test Cassette (Serum/Plasma) GCSYP-302a98/79	– 98/79	sales@orientgene.com EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain)	South Korea	H. pylori Antibody Rapid Test Cassette/Strip HIHP-402/HIHP-40198/79 H. pylori Antigen Rapid Test Cassette HIHPG-60298/79 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
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	– 98/79	EUDAMED record Report an error
PRIMA Lab EU representative : QbD RepS BV (Belgium)	Switzerland	Autotest Helicobacter pylori98/79 Dr. Max Helicobacter pylori test 800017-x98/79 GetTested STREP A TEST98/79 TEST AUTODIAGNOSTICO HELICOBACTER PYLORI98/79	– 98/79	quality@primahometest.com 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
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany)	Egypt	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	– 98/79	Website EUDAMED record Report an error
Aaz Productions Le Materiel Biomedical	France	SYPHILIS ALL IN® TR-SYP-00198/79 TetaQuick98/79 TROD'ANGINE2 refs98/79	– 98/79	EUDAMED record Report an error
Cesna	Türkiye	H.PYLORI AB HIZLI TESTİ H.PYLORI AG HIZLI TESTİ STREP HIZLI TEST KİTİ KONTROLÜ	B IVDR	Website info@cesna.com.tr EUDAMED record Report an error
Dyonmed	Greece	DyonHpsA98/79 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
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold)98/79 Strep A Antigen Rapid Test (Immunochromatography)98/79 Streptococcus Pneumoniae Antigen Rapid Test98/79	– 98/79	Website EUDAMED record Report an error
Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Sti	Türkiye	CERTAIN3 refs98/79 LABOQUICK2 refs98/79 SURELAB2 refs98/79	– 98/79	Website info@koroglugroup.com EUDAMED record Report an error
Labnovation EU representative : MedNet EC-REP GmbH (Germany)	China	H. Pylori Antibody Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 H. Pylori 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
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	LYSUN HP-F21（25PCS）98/79 LYSUN STP-S21（25PCS）98/79 LYSUN SYP-W21（25PCS）98/79	– 98/79	EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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 Strep A antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
Mpbio FDA EU representative : MP Biomedicals Germany GmbH (Germany)	Germany, Singapore	MP Diagnostics ASSURE H. pylori Antigen Rapid Test98/79 MP Diagnostics ASSURE H. pylori Rapid Test98/79 Rapid H.pylori Antigen Test Card98/79	– 98/79	Website EUDAMED record Report an error
Nano Diagnosis for Health Biotech (Guangzhou) EU representative : MedPath GmbH (Germany)	China	H.Pylori Antibody Rapid Test HPAB-0298/79 H.Pylori Antigen Rapid Test HPAG-01、HPAG-0298/79 Syphilis Rapid Test SYP-01、SYP-0298/79	– 98/79	EUDAMED record Report an error
Shenzhen Kang Sheng Bao Bio-Technology EU representative : QbD RepS BV (Belgium)	China	H.pylori Ab Rapid Test98/79 H.pylori Ag Rapid Test98/79 Strep A Rapid Test98/79	– 98/79	Website info@ksbbiotech.com 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
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	Flowflex5 refs98/79 Quik-Check4 refs98/79	– 98/79	Website EUDAMED record Report an error
Anbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	BOIRON A10013001D98/79 Group A Streptococcus Test Kit A0216700298/79	– 98/79	info@anbio.com 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	– 98/79	Website EUDAMED record Report an error
Atlas Medical FDA	Germany	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	– 98/79	Website info@atlas-medical.com EUDAMED record Report an error
Biohit FDA	Finland	BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 UFT3004 refs98/79 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 quick test98/79	– 98/79	Website info@biohit.fi 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
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	1 test/kit98/79 25 tests/kit98/79	– 98/79	info@genesignbio.com EUDAMED record Report an error
Hangzhou Genesis Biodetection Biocontrol FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Legionella Antigen Rapid Test Device P24111098/79 Strep B Antigen Rapid Test P28100398/79	– 98/79	Website EUDAMED record Report an error
Human	Germany	Syphilis RPR Test3 refs98/79 Syphilis TPHA liquid98/79	– 98/79	Website 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	– 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	– 98/79	info@konsung.com 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
Nexlab EU representative : MedNet EC-REP GmbH (Germany)	China	POCBio Syphilis Antibody Rapid Test LATB04-C2598/79 POCBio Syphilis Antibody Rapid Test LATB04-C5098/79	– 98/79	EUDAMED record Report an error
Sejoy FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	H.pylori Antibody Rapid Test Cassette98/79 Syphilis Antibody Rapid Test Cassette,Strip98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen Huian Biosci Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	1T/Kit2 refs98/79 20T/Kit2 refs98/79	– 98/79	info@huiantech.com EUDAMED record Report an error
Synthgene (Yixing) Health Technology EU representative : MedPath GmbH (Germany)	China	Strep A Antigen Rapid Test Kit (Colloidal gold method)98/79 Strep B Antigen Rapid Test Kit(Colloidal gold method)98/79	– 98/79	sales@syngenebio.com EUDAMED record Report an error
Wondfo FDA EU representative : QbD RepS BV (Belgium)	China	One Step Chlamydia Swab / Urine Test98/79 One Step Strep A Swab Test3 refs98/79	– 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
Acmexbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Acmex Cassette4 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
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruVue3 refs98/79	– 98/79	EUDAMED record Report an error
Calth EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	AllCheck Syphilis Anti-TP CHR20	C IVDR	Website info@thecalth.com EUDAMED record Report an error
Campmedica	Romania	See Now98/79	– 98/79	Website EUDAMED record Report an error
Cupidlimited FDA EU representative : Amstermed B.V. (Netherlands)	India	CupiKIT	C IVDR	Website qa@cupidlimited.com EUDAMED record Report an error
Daltonbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	/98/79	– 98/79	Website EUDAMED record Report an error
Diesse FDA	Italy	RPR-DAT TREPONEMADAT	C IVDR	Website 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
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	H. pylori Fast Test Kit (Immunofluorescence Assay)98/79	– 98/79	EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	101A0202EY98/79	– 98/79	ra.danwei@danwei-bio.com EUDAMED record Report an error
InTec PRODUCTS EU representative : QbD RepS BV (Belgium)	China	ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST ITP030042 refs98/79	– 98/79	Website EUDAMED record Report an error
Jiangsu Medomics Medical Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Group A streptococcus Rapid test Kit98/79	– 98/79	Website info@medomics-dx.com EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Medunion S.L. (Spain)	China	Strep A Antigen Test Kit R226T020B0C098/79	– 98/79	EUDAMED record Report an error
Lifotronic FDA EU representative : Umedwings Netherlands B.V. (Netherlands)	China	H.Pylori Ag Test (GICA) 25 Tests/Kit98/79	– 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
Ortho-Clinical Diagnostics Summers Ridge San Diego EU representative : MDSS GmbH (Germany)	United States	Sofia Strep A+ FIA 25T98/79	– 98/79	Website PRRC@quidelortho.com 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
R-Biopharm FDA	Germany	RIDA®Quick C. difficile GDH Toxin A/B Combi2 refs	B IVDR	Website 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
Zetmedikal	Türkiye	SOFTEC Syphilis Rapid Test Kit (Cassette) SFSPRT4098/79	– 98/79	Website info@zetmedikal.com 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) H. pylori Antibody Rapid Test98/79 (no longer marketed) H.pylori Antigen Rapid Test98/79 (no longer marketed) 2 others Strep A Rapid Test98/79 (no longer marketed) Treponema Pallidum Antibody Rapid Test98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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