Infectious diseasesInfectious immunology - rapid tests & point of careBacteriology - RT & POC

Bacteriology - RT & POC - other

EMDN code W0105090199

68 manufacturers, 732 models including 722 on the market, 15 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 68

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
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	United States	Bacterial Diarrhea (Shigella/Cholerae/C.diff) Rapid Test98/79 Bacterial Diarrhea (Shigella/Salmonella/C.diff) Rapid Test98/79 Bordetella pertussis Antigen Rapid Test B-IBP-ACO502VN98/79 Brucella Abortus and Melitensis Antibody Combo Rapid Test98/79 Brucella Abortus Antibody Rapid Test98/79 80 others Brucella Abortus Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Brucella Abortus IgG/IgM Rapid Test98/79 Campylobacter Rapid Test Cassette (Feces) ICAM-60298/79 Campylobacter Rapid Test Cassette acrCAM602R98/79 Campylobacter Rapid Test ICAM-ACO60798/79 Candida albicans and Trichomonas Vaginalis Combo Rapid Test ICT-ACO52598/79 Candida albicans Rapid Test Cassette (Vaginal Swab) ICA-R50298/79 CARBA-5 Rapid Test98/79 Cryptococcus Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma/ Cerebral Spinal Fluid (CSF)) ICRG-R40298/79 Febrile Antigens17 refs98/79 Gardnerella Vaginalis Antigen Rapid Test98/79 Gonorrhea Rapid Test Cassette (Swab)98/79 H. pylori Antibody Rapid Test Cassette (Serum /Plasma) IHP-R30298/79 H. pylori Antibody Rapid Test Cassette IHP-R40298/79 H. pylori Antigen Rapid Test IHP-ACO60798/79 H. pylori Rapid Test IHP-ACO90198/79 H. pylori Rapid Test IHP-ACO90298/79 H. pylori Rapid Test IHP-ACO90498/79 H.pylori IgM Rapid Test IHPM-ACO40298/79 H.pylori/Transferrin Combo Rapid Test IHT-ACO62598/79 H.pylori Saliva (HPS) Rapid Test98/79 Legionella pneumophila Rapid Test Cassette98/79 Leptospira IgG/IgM Combo Rapid Test ILEP-ACO42598/79 Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) ILEP-R40298/79 Leptospira IgG/IgM Test Cassette ACO-LEP-40298/79 Leptospira IgM Rapid Test ILEPM-ACO40298/79 Leptospira IgM Semi-quantitative Rapid Test ILEM-ACO42598/79 Lyme IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) ILY-R40298/79 Lyme IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) ILY-40298/79 Melioidosis (Burkholderia pseudomallei) IgG/IgM Rapid Test98/79 Mycobacterium Tuberculosis Antigen Rapid Test98/79 Mycoplasma Genitalium (MG) IgG Rapid Test98/79 Mycoplasma pneumoniae Antigen Rapid Test Cassette (Throat Swab)98/79 Mycoplasma pneumoniae Antigen Test Cassette ACO-MP-50298/79 Rose Bengal Latex Reagents98/79 S. pneumoniae and L. pneumophila Combo Rapid Test Cassette (Urine)2 refs98/79 S. pneumoniae Antigen Rapid Test Cassette ISP-R10298/79 Salmonella paratyphi Antigen Rapid Test98/79 Salmonella paratyphi Antigen Rapid Test Cassette (Feces)98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test Cassette (Feces)98/79 Salmonella typhi and paratyphi B Antigen Combo Rapid Test2 refs98/79 Salmonella typhi and paratyphi B Antigen Combo Rapid Test (Feces)98/79 Salmonella Typhi Antigen Rapid Test98/79 Salmonella typhi and paratyphi B Antibody Combo Rapid Test98/79 Scrub Typhus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)2 refs98/79 Scrub Typhus IgG/IgM Test Cassette98/79 Shigella Flexneri Antigen Rapid Test98/79 Shigella Flexneri Antigen Rapid Test Cassette98/79 Shigella Flexneri Antigen Rapid Test Cassette (Feces)98/79 Shigella Rapid Test Cassette (Feces) ISH-R62598/79 Shigella Rapid Test ISH-ACO62798/79 Shigella Sonnei Antigen Rapid Test98/79 Shigella Sonnei Antigen Rapid Test Cassette98/79 Shigella Sonnei Antigen Rapid Test Cassette (Feces)98/79 Tetanus Rapid Test Cassette (Whole Blood/Serum/Plasma) ITE-R40298/79 Tetanus Rapid Test Cassette ITE-R402SQ98/79 TGAb Test Cassette98/79 TPOAb Test Cassette98/79 Trichomonas Vaginalis Rapid Test Cassette acrTV502R98/79 Tuberculosis Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Tuberculosis IgG/IgM Rapid Test Cassette98/79 Tuberculosis Rapid Test Cassette2 refs98/79 Tuberculosis Rapid Test Dipstick (Whole Blood/Serum/Plasma)98/79 Typhoid IgG Rapid Test Cassette98/79 Typhoid IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Typhoid IgM Rapid Test Cassette98/79 Typhoid IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Typhoid Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Typhoid Rapid Test Cassette (Serum/Plasma)98/79 Vibrio cholera O1 Inaba (VC O1 Inaba) Rapid Test Cassette (Feces)98/79 Vibrio Cholera O1 Ogawa (VC O1 Ogawa) Rapid Test Cassette (Feces)98/79 Vibrio cholerae O1/O139 Combo Rapid Test Cassette (Feces)2 refs98/79 Vibrio cholerae O1 (VC O1) Rapid Test Cassette (Feces)2 refs98/79 Vibrio Cholerae O1 Inaba (VC O1 Inaba) Rapid Test Cassette (Feces)98/79 Vibrio Cholerae O1 Ogawa (VC O1 Ogawa) Rapid Test Cassette (Feces)98/79 Vibrio cholerae O1/O139 Combo Rapid Test98/79 Vibrio cholerae O139 (VC O139) Rapid Test Cassette (Feces)2 refs98/79 Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test (Feces)2 refs98/79 Vibrio Cholerae O139,O1 Ogawa & Inaba Combo Rapid Test2 refs98/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	ASO Test Cassette98/79 Bacterial Diarrhea (Salmonella/C.diff)Rapid Test98/79 Bacterial Diarrhea (Shigella/Cholerae/C.diff) Rapid Test98/79 Bacterial Diarrhea (Shigella/Salmonella) Rapid Test98/79 Bacterial Diarrhea (Shigella/Salmonella/C.diff) Rapid Test98/79 74 others Bordetella pertussis Antigen Rapid Test IBP-50298/79 Bordetella pertussis IgM Rapid Test IBPM-40298/79 Brucella Abortus and Melitensis Antibody Combo Rapid Test98/79 Brucella Abortus Antibody Rapid Test98/79 Brucella Abortus Antigen Rapid Test Cassette98/79 Brucella Abortus IgG/IgM Rapid Test98/79 Campylobacter Prueba Rápida de Casete98/79 Campylobacter Rapid Test Cassette (Feces) ICAM-60298/79 Campylobacter Rapid Test Cassette ICAM-R60298/79 Campylobacter Rapid Test ICAM-60798/79 Candida albicans and Trichomonas Vaginalis Combo Rapid Test ICT-52598/79 CARBA-5 Rapid Test98/79 Clostridium difficile GDH+Toxin A+Toxin B Combo Rapid Test ICD-63798/79 Febrile Antigens10 refs98/79 Gardnerella Vaginalis Antigen Rapid Test98/79 Gonorrhea Rapid Test4 refs Gonorrhea Rapid Test Cassette98/79 Gonorrhea Rapid Test W010509019998/79 H. pylori Antibody Rapid Test Cassette IHP-R40298/79 H. pylori Antigen Rapid Test Cassette MH-HP-602H98/79 H.pylori IgM Rapid Test IHPM-40298/79 H.pylori Rapid Test IHP-90498/79 H.pylori Saliva (HPS) Rapid Test98/79 H.pylori/Transferrin Combo Rapid Test IHT-62598/79 Helicobacter Pylori (HP) IgA Test Kit (CLIA)98/79 Leptospira IgG/IgM Combo Rapid Test ILEP-42598/79 Leptospira IgG/IgM Test Cassette FI-LEP-40298/79 Leptospira IgM Rapid Test ILEPM-40298/79 Leptospira IgM Semi-quantitative Rapid Test ILEM-42598/79 Lyme IgG/IgM Rapid Test Cassette ILY-40298/79 Melioidosis (Burkholderia pseudomallei) IgG/IgM Rapid Test98/79 Mycobacterium Tuberculosis Antigen Rapid Test98/79 Mycoplasma Genitalium (MG) IgG Rapid Test98/79 Mycoplasma Pneumoniae Antigen Test Cassette FI-MP-50298/79 Mycoplasma Pneumoniae IgG Rapid Test IMPG-40298/79 Mycoplasma pneumoniae IgG/IgM ComboRapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Mycoplasma pneumoniae IgG/IgM Rapid Test IMP-40298/79 Mycoplasma pneumoniae IgM Test Cassette FI-MPM-40298/79 Rose Bengal Latex Reagents98/79 S. pneumoniae and L. pneumophila Combo Rapid Test Cassette98/79 S. pneumoniae and L. pneumophila Combo Rapid Test Cassette (Urine)98/79 Salmonella paratyphiAntigen Rapid Test98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test98/79 Salmonella typhi and paratyphi B Antibody Combo Rapid Test98/79 Salmonella typhi and paratyphi B Antigen Combo Rapid Test2 refs98/79 Salmonella typhi Antigen Rapid Test4 refs Salmonella typhi AntigenRapid Test Cassette(Feces)98/79 Scrub Typhus IgG/IgM Rapid Test Cassette2 refs98/79 Scrub Typhus IgG/IgM Test Cassette98/79 Shigella Flexneri Antigen Rapid Test98/79 Shigella Flexneri Antigen Rapid Test Cassette98/79 Shigella Sonnei Antigen Rapid Test98/79 Shigella Sonnei Antigen Rapid Test Cassette98/79 ShigellaRapid Test98/79 Streptococcus pneumoniae and Legionella pneumophila Combo Rapid Test Cassette2 refs98/79 Syphilis Rapid Test ISY-10298/79 Tetanus Rapid Test Cassette ITE-40298/79 Tuberculosis IgG/IgM Rapid Test Cassette98/79 Tuberculosis Rapid Test Cassette2 refs98/79 Tuberculosis Rapid Test Dipstick98/79 Typhoid IgG Rapid Test Cassette98/79 Typhoid IgM Rapid Test Cassette98/79 Typhoid Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Vibrio cholerae O1 (VC O1) Rapid Test Cassette2 refs98/79 Vibrio cholerae O1 (VC O1) Rapid Test Cassette (Feces)98/79 Vibrio Cholerae O1 Inaba (VC O1 Inaba) Rapid Test Cassette2 refs98/79 Vibrio Cholerae O1 Ogawa (VC O1 Ogawa) Rapid Test Cassette2 refs98/79 Vibrio cholerae O1/O139 Combo Rapid Test98/79 Vibrio cholerae O1/O139 Combo Rapid Test Cassette2 refs98/79 Vibrio cholerae O1/O139 Combo Rapid Test Cassette (Feces)98/79 Vibrio cholerae O139 (VC O139) Rapid Test98/79 Vibrio cholerae O139 (VC O139) Rapid Test Cassette98/79 Vibrio cholerae O139 (VC O139) Rapid Test Cassette (Feces)98/79 Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test4 refs98/79	C IVDR, 98/79	info@alltests.com.cn EUDAMED record Report an error
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain)	United States	Bacterial Diarrhea (Shigella/Cholerae/C.diff) Test98/79 Bacterial Diarrhea (Shigella/Salmonella/C.diff) Test98/79 Bordetella pertussis Ag Test SW02-BP98/79 Bordetella pertussis IgM Test BSP02-BPM98/79 Brucella Abortus Ab Test98/79 48 others Brucella Abortus Ag Test98/79 Campylobacter Test F02-CAM98/79 Campylobacter Test F07-CAM98/79 Candida albicans and Trichomonas Vaginalis Combo Test SW25-CT98/79 Candida albicans Test SW02-CA98/79 Cryptococcus Ag Test BSPC02-CRY98/79 Gonorrhea Test98/79 H. pylori Ag Test F01-HP98/79 H. pylori Ag Test F02-HP98/79 H. pylori Ag Test F07-HP98/79 H. pylori Antibody Test BSP01-HP98/79 H. pylori Antibody Test BSP02-HP98/79 H. pylori Antibody Test SP02-HP98/79 H. pylori Antigen FIA Test98/79 H.pylori/Transferrin Combo Test F25-HT98/79 Leptospira IgG/IgM Combo Test BSP25-LEPB98/79 Leptospira IgG/IgM FIA Test98/79 Leptospira IgG/IgM Test BSP02-LEPB98/79 Lyme IgG/IgM Test BSP02-LYB98/79 Mycobacterium Tuberculosis Ag Test98/79 Mycoplasma pneumoniae Ag Test SW02-MP98/79 Mycoplasma pneumoniae FIA Test98/79 Mycoplasma Pneumoniae IgG/IgM Combo Test BSP25-MPB98/79 Mycoplasma Pneumoniae IgM Test BSP02-MPM98/79 Salmonella paratyphi Ag Test2 refs98/79 Salmonella typhi & paratyphi Ag Combo Test2 refs98/79 Salmonella typhi & paratyphi B Ag Combo Test2 refs98/79 Salmonella typhi Ag Test2 refs98/79 Scrub Typhus IgG/IgM FIA Test98/79 Scrub Typhus IgG/IgM Test98/79 Shigella Combo Test F25-SH98/79 Shigella Flexneri Ag Test2 refs98/79 Shigella Sonnei Ag Test2 refs98/79 Streptococcus pneumoniae & Legionella pneumophila Combo Test98/79 Tetanus IgG FIA Test98/79 Tetanus Test BSP02-TET98/79 Trichomonas Vaginalis Test SW02-TV98/79 Tuberculosis (TB) Test2 refs98/79 Typhoid FIA Test98/79 Typhoid IgG Test98/79 Typhoid IgG/IgM Test3 refs98/79 Typhoid IgM Test98/79 Vibrio cholerae O1 (VC O1) Test98/79 Vibrio Cholerae O1 Inaba (VC O1 Inaba) Test98/79 Vibrio Cholerae O1 Ogawa (VC O1 Ogawa) Test98/79 Vibrio Cholerae O1/O139 Combo Test2 refs98/79 Vibrio cholerae O139 (VC O139) Test98/79 Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Test2 refs98/79	– 98/79	info@acesolab.com EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain)	China	Brucella Abortus Antigen Rapid Test98/79 Campylobacter Rapid Test L11-CAM01C698/79 Candida albicans Rapid Test L11-CA01C598/79 Cryptococcus Antigen Rapid Test L11-CRG01C498/79 Gonorrhea Rapid Test98/79 47 others H. pylori Antigen Assay F11-HP01C698/79 Leptospira IgG/IgM Assay F11-LEP01C498/79 Leptospira IgG/IgM Rapid Test L11-LEP01C498/79 Lyme IgG/IgM Rapid Test L11-LYGM01C498/79 Mycoplasma pneumoniae Antigen Assay F11-MP01C598/79 Mycoplasma pneumoniae Antigen Rapid Test L11-MP01C598/79 Mycoplasma Pneumoniae IgG/IgM Combo Rapid Test L11-MPB02C498/79 Mycoplasma Pneumoniae IgM Rapid Test L11-MPM01C498/79 One Step Brucella Abortus IgG/IgM Test98/79 One Step Brucella Abortus&Melitensis Antibody Combo Test98/79 One Step Candida albicans and Trichomonas Vaginalis Combo Test98/79 One Step CARBA-5 Test98/79 One Step Gardnerella Vazinalis Antigen Test98/79 One Step H. pylori Test2 refs98/79 One Step H.pylori IgM Test98/79 One Step H.pylori Saliva (HPS) Test98/79 One Step Leptospira IgM Semi-quantitative Test98/79 One Step Melioidosis (Burkholderia pseudomallei) IgG/IgM Test98/79 One Step Mycobacterium Tuberculosis Antigen Test98/79 One Step Mycoplasma Genitalium (MG) IgG Test98/79 One Step Salmonella typhi and paratyphi B Antigen Combo Test2 refs98/79 One Step Salmonella typhi and paratyphi B Antibody Combo Test98/79 One Step Shigella Flexneri Antigen Test2 refs98/79 One Step Shigella Sonnei Antigen Test2 refs98/79 One Step Shigella Test2 refs98/79 One Step Vibrio Cholerae O1 Inaba (VC O1 Inaba) Test98/79 One Step Vibrio Cholerae O1 Ogawa (VC O1 Ogawa) Test98/79 One Step Vibrio Cholerae O139,O1 Ogawa & Inaba Combo Test2 refs98/79 One Step Campylobacter Test98/79 One Step Salmonella paratyphi Antigen Test98/79 One Step Salmonella typhi and paratyphi Antigen Combo Test98/79 One Step Salmonella typhi Antigen Test98/79 One Step Vibrio Cholerae O1/O139 Combo Test98/79 S.pneumoniae and L.pneumophila Combo Rapid Test98/79 Salmonella paratyphi Antigen Rapid Test98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test98/79 Salmonella typhi Antigen Rapid Test98/79 Scrub Typhus IgG/IgM Assay98/79 Scrub Typhus IgG/IgM Rapid Test98/79 Tetanus IgG Assay F11-TET01C498/79 Tetanus Rapid Test L11-TET01C498/79 Trichomonas Vaginalis Rapid Test L11-TV01C598/79 Typhoid Assay98/79 Typhoid IgG/IgM Rapid Test3 refs98/79 Vibrio cholerae O1 (VC O1) Rapid Test98/79 Vibrio cholerae O1/O139 Combo Rapid Test98/79 Vibrio cholerae O139 (VC O139) Rapid Test98/79	– 98/79	Website info@kylinew.com EUDAMED record Report an error
Tongzhoubio FDA EU representative : VidaQuick Biotech S.L. (Spain)	China	Bacterial Diarrhea (Shigella/Salmonella/C.diff) Rapid Test98/79 Bordetella pertussis Antigen Rapid Test I167-500298/79 Brucella Abortus Antigen Rapid Test98/79 Campylobacter Rapid Test I017-600298/79 Candida albicans and Trichomonas Vaginalis Combo Rapid Test I153-502598/79 47 others Candida albicans Rapid Test I001-500298/79 CARBA-5 Rapid Test98/79 Clostridium difficile GDH Rapid Test I018-600298/79 Clostridium difficile GDH+Toxin A+Toxin B Combo Rapid Test I020-6035B98/79 Clostridium difficile Toxin A+Toxin B Combo Rapid Test I019-6025B98/79 Cryptococcus Antigen Rapid Test I080-400298/79 Gonorrhea Rapid Test98/79 H. pylori Antibody Rapid Test (Serum/Plasma) I021-300298/79 H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma) I021-400198/79 H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma) I021-400298/79 H. pylori Antigen Rapid Test Cup I021-600798/79 H. pylori Antigen Rapid Test I021-600198/79 H. pylori Antigen Rapid Test I021-600298/79 H.pylori Antigen Test Kit YI060-600298/79 Leishmania IgG/IgM Rapid Test I037-400298/79 Leptospira IgG/IgM Rapid Test I038-400298/79 Lyme IgG/IgM Rapid Test I058-400298/79 Mycobacterium tuberculosis Antigen Rapid Test98/79 Mycoplasma pneumoniae Antigen Rapid Test I048-500298/79 Mycoplasma Pneumoniae IgG Rapid Test I175-400298/79 Mycoplasma Pneumoniae IgG/IgM Combo Rapid Test I048-402598/79 Mycoplasma Pneumoniae IgM Rapid Test I074-400298/79 S. pneumoniae and L. pneumoohila Combo Rapid Test98/79 Salmonella paratyphi Antigen Rapid Test98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test98/79 Salmonella typhi and paratyphi B Antigen Combo Rapid Test98/79 Salmonella typhi Antigen Rapid Test2 refs98/79 Scrub Typhus IgG/IgM Rapid Test98/79 Shigella Flexneri Antigen Rapid Test98/79 Shigella Rapid Test I132-602598/79 Shigella Rapid Test I132-602798/79 Shigella Sonnei Antigen Rapid Test98/79 Syphilis Rapid Test (S/P) I044-300198/79 Syphilis Rapid Test (S/P) I044-300298/79 Syphilis Rapid Test I044-400198/79 Syphilis Rapid Test I044-400298/79 Syphillis Test Kit98/79 Tetanus Rapid Test I059-400298/79 Typhoid IgG/IgM Rapid Test (Serum/Plasma)98/79 Typhoid IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)2 refs98/79 Typhoid Test Kit98/79 Vibrio cholerae O1 (VC O1) Rapid Test98/79 Vibrio Cholerae O1 Inaba (VC O1 Inaba) Rapid Test98/79 Vibrio Cholerae O1 Ogawa (VC O1 Ogawa) Rapid Test98/79 Vibrio cholerae O1/O139 Combo Rapid Test2 refs98/79 Vibrio cholerae O139 (VC O139) Rapid Test98/79 Vibrio Cholerae O139,O1 Ogawa & Inaba Combo Rapid Test2 refs98/79	– 98/79	EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain)	China	Brucella Abortus Antigen Rapid Test Cassette98/79 Campylobacter Rapid Test CAM-7-F98/79 Campylobacter Rapid Test Cassette CAM-2-F98/79 Candida albicans and Trichomonas Vaginalis Combo Rapid Test CT-5-E98/79 Candida albicans Rapid Test Cassette CA-2-E98/79 43 others Candida albicans Rapid Test Cassette CA-2-Ez98/79 Candida albicans Rapid Test Cassette CAA-2-E98/79 Cryptococcus Antigen Rapid Test Cassette CRY-2-D98/79 Gonorrhea Rapid Test Cassette98/79 H. pylori Antibody Rapid Test Cassette HP-2-C98/79 H. pylori Antibody Rapid Test Cassette HP-2-D98/79 H. pylori Antibody Rapid Test Dipstick98/79 H. pylori Antigen Rapid Test Cassette HP-2-F98/79 H. pylori Antigen Rapid Test Dipstick98/79 H. pylori Antigen Rapid Test HP-4-O98/79 H.pylori Antigen Rapid Test HP-7-F98/79 H.pylori/Transferrin Combo Rapid Test HPTF-5-F98/79 Leptospira IgG/IgM Combo Rapid Test LGM-5-D98/79 Leptospira IgG/IgM Rapid Test Cassette LGM-2-D98/79 Lyme IgG/IgM Rapid Test Cassette LYGM-2-D98/79 Mycobacterium tuberculosis Antigen Rapid Test98/79 Mycoplasma Pneumoniae IgG/IgM Combo Rapid Test Cassette MPGM-5-D98/79 Salmonella paratyphi Antigen Rapid Test98/79 Salmonella paratyphi Antigen Rapid Test Cassette98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test Cassette98/79 Salmonella typhi and paratyphi B Antigen Combo Rapid Test98/79 Salmonella typhi Antigen Rapid Test98/79 Salmonella typhi Antigen Rapid Test Cassette98/79 Scrub Typhus IgG/IgM Rapid Test Cassette98/79 Shigella Flexneri Antigen Rapid Test98/79 Shigella Rapid Test Cassette SHI-5-F98/79 Shigella Rapid Test SHI-7-F98/79 Shigella Sonnei Antigen Rapid Test98/79 Streptococcus pneumoniae and Legionella pneumophila Combo Rapid Test Cassette98/79 Tetanus Rapid Test Cassette TET-2-D98/79 Trichomonas Vaginalis Rapid Test Cassette TRV-2-E98/79 Trichomonas Vaginalis Rapid Test Cassette TRV-2-Ez98/79 Tuberculosis (TB) Rapid Test Cassette98/79 Tuberculosis (TB) Rapid Test Dipstick98/79 Typhoid Rapid Test3 refs98/79 Vibrio choierae O1/O139 Combo Rapid Test Cassette98/79 Vibrio cholerae O1 (VC O1) Rapid Test Cassette98/79 Vibrio Cholerae O1 Inaba (VC O1 Inaba) Rapid Test Cassette98/79 Vibrio Cholerae O1 Ogawa (VC O1 Ogawa) Rapid Test Cassette98/79 Vibrio Cholerae O1/O139 Combo Rapid Test98/79 Vibrio cholerae O139 (VC O139) Rapid Test Cassette98/79 Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test Cassette2 refs98/79	– 98/79	info@actest.com.cn EUDAMED record Report an error
Bitrumed EU representative : VidaQuick Biotech S.L. (Spain)	China	Brucella Abortus Ag Test98/79 Campylobacter Test CAM-6C198/79 Candida albicans Test CA-5C198/79 Cryptococcus Ag Test CRY-4C198/79 Gonorrhea Test98/79 29 others H. pylori Ag Test HP-6A198/79 H. pylori Ag Test HP-6C198/79 H. pylori Ag Test HP-6F198/79 H. pylori Antibody Rapid Test Cassette IHP-30298/79 H. pylori Antibody Rapid Test Cassette IHP-40298/79 H. pylori Antibody Test HP-3C198/79 H. pylori Antibody Test HP-4A198/79 H. pylori Antibody Test HP-4C198/79 H.pylori Antigen Rapid Test Cassette IHP-60298/79 Leptospira IgG/IgM Test LEP-4C198/79 Lyme IgG/IgM Test LY-4C198/79 Mycoplasma pneumoniae Ag Test MP-5C198/79 Mycoplasma Pneumoniae Antigen Rapid Test Cassette IMP-50298/79 Mycoplasma Pneumoniae IgG/IgM Combo Test MPB-4C298/79 Mycoplasma pneumoniae IgM Rapid Test Cassette IMPM-40298/79 Mycoplasma Pneumoniae IgM Test MPM-4C198/79 Salmonella paratyphi Ag Test98/79 Salmonella typhi & paratyphi Ag Test98/79 Salmonella typhi Ag Test98/79 Scrub Typhus IgG/IgM Test98/79 Shigella Test SH-6C298/79 Streptococcus pneumoniae & Legionella pneumophila Combo Test98/79 Tetanus Test TET-4C198/79 Trichomonas Vaginalis Test TV-5C198/79 Tuberculosis (TB) Test2 refs98/79 Typhoid IgG/IgM Test3 refs98/79 Vibrio cholerae O1/O139 Test98/79 Vibrio cholerae O1 (VC O1) Test98/79 Vibrio cholerae O139 (VC O139) Test98/79	– 98/79	info@bitrumed.com.cn EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) and 1 other	United Kingdom (ex Northern Ireland)	Campylobacter Rapid Test Device – Feces D-CAMD1098/79 Candida Albicans Rapid Test Device-Swab D-CAND0198/79 Candida Albicans Rapid Test Device-Swab D-CAND1098/79 Candida Albicans Rapid Test Device-Swab D-CAND2098/79 CARBA-5 Rapid Test-Culture98/79 26 others Cholera Ag O139 Rapid Test Device – Feces98/79 Gardnerella vaginalis Antigen Rapid Test Device98/79 H. pylori Antibody Rapid Test Device-WB/S/P2 refs98/79 H. pylori Antigen Rapid Test-Feces D-HPAGC1098/79 H. pylori Antigen Test Device-Feces D-FIHPD1098/79 H. pylori Antigen Test Device-Feces D-FIHPD2598/79 H. pylori Rapid Test -Tartar D-HPTD1098/79 Leptospira IgG/IgM Test Device-Fingerstick WB, WB/S/P2 refs98/79 Leptospira IgM Rapid Test Device-WB/S/P98/79 Mycobacterium tuberculosis Antigen Rapid Test Device-Sputum Culture98/79 Mycoplasma pneumoniae Antigen Test Device -Throat Swab98/79 Salmonella typhi and paratyphi B Antigen Rapid Test Device - Feces98/79 Scrub Typhus IgG/IgM Rapid Test Device – WB/S/P98/79 Scrub Typhus IgG/IgM Test Device-Fingerstick WB, WB/S/P2 refs98/79 Tetanus IgG Test Device-Fingerstick WB, WB/S/P2 refs98/79 Tuberculosis (TB) Rapid Test Device – WB/S/P98/79 Tuberculosis IgG/IgM Rapid Test Device-WB/S/P98/79 Tuberculosis Rapid Test Strip-WB/S/P98/79 Typhoid Test Device -Fingerstick WB, WB/S/P2 refs98/79 Vibrio cholerae O1/O139 Combo Rapid Tes tDevice - Feces98/79 Vibrio cholerae O1 (VC O1) Rapid Test Device - Feces98/79 Vibrio Cholerae O1 Inaba Rapid Test Device98/79 Vibrio Cholerae O1 Ogawa Rapid Test Device98/79 Vibrio cholerae O139 (VC O139) Rapid Test Device - Feces98/79 Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test (Feces)98/79 Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test Device98/79	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Biotical	Spain	biotical Campylobacter Card98/79 biotical Campylobacter Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Campylobacter +1 C. Negativo universal)98/79 biotical Campylobacter Card (+PC)98/79 biotical E. Coli O157:H7 Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo E. Coli O157:H7 +1 C. Negativo universal)98/79 biotical E. Coli O157:H7 Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo E. Coli O157:H7)98/79 18 others biotical E. Coli O157:H7 Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79 biotical S. typhi Positive control (1u) / 1 unidad de hisopo de control positivo Salmonella typhi.98/79 biotical S. typhi Positive control (30u) / 30 controles positivos Salmonella typhi (sin test rápido)98/79 biotical Salmonella Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Salmonella +1 C. Negativo universal)98/79 biotical Salmonella Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Salmonella)98/79 biotical Salmonella Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79 biotical Salmonella paratyphi Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Salmonella paratyphi +1 C. Negativo universal)98/79 biotical Salmonella paratyphi Card (+PC)98/79 biotical Salmonella paratyphi Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79 biotical Salmonella typhi Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Salmonella typhi +1 C. Negativo universal)98/79 biotical Salmonella typhi Card (+PC)98/79 biotical Salmonella typhi Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79 biotical Yersinia enterocolitica O:3 Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Yersinia enterocolitica O:3 +1 C. Negativo universal)98/79 biotical Yersinia enterocolitica O:3 Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Yersinia enterocolitica O:3)98/79 biotical Yersinia enterocolitica O:3 Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79 biotical Yersinia enterocolitica O:9 Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Yersinia enterocolitica O:9 +1 C. Negativo universal)98/79 biotical Yersinia enterocolitica O:9 Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Yersinia enterocolitica O:9)98/79 biotical Yersinia enterocolitica O:9 Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79	– 98/79	Website EUDAMED record Report an error
Ameritech Diagnostic Reagent (Jiaxing) EU representative : CEpartner4U (Netherlands)	China	R09-11098/79 R09-11298/79 R09-11698/79 R09-C-11098/79 R09-C-11298/79 15 others R09-C-11698/79 R104-11098/79 R104-11298/79 R105-11098/79 R105-11298/79 R106-11098/79 R106-11298/79 R300-11098/79 R300-11298/79 R305-11098/79 R305-11298/79 R36-11098/79 R36-11298/79 R97-11298/79 V0498/79	– 98/79	EUDAMED record Report an error
Safecare FDA EU representative : UnicareQ GmbH (Germany) and 1 other	China	Brucella IgG/IgM Rapid Test (Serum/Plasma) Bru-302298/79 Brucella IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) BRU-402298/79 Brucella IgG/IgM Rapid Test(WB/S/P)98/79 Cholera O1 Antigen Rapid Test98/79 Cholera O1 Antigen Rapid Test(Feces)98/79 11 others Gonorrhoea Rapid Test Kit(Swab)98/79 Gonorrhoea Rapid Test(Swab)98/79 Legionella & S.pneumoniae Antigen Combo Rapid Test(Urine) MID-102298/79 S.Typhi Antigen Rapid Test (Feces)98/79 S.Typhi(TYP) Antigen Rapid Test (Feces)98/79 Tuberculosis Rapid Test (Serum/Plasma)98/79 Tuberculosis Rapid Test (Whole Blood/Serum/Plasma)98/79 Tuberculosis Rapid Test Kit(Whole Blood/serum/plasma)98/79 Typhoid IgG/IgM Rapid Test (Serum/Plasma)98/79 Typhoid IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 Typhoid IgG/IgM Rapid Test Kit (Whole Blood/serum/plasma)98/79	– 98/79	EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	LYHER ITB-402-0198/79 LYHER ITB-402-0298/79 LYHER ITB-402-0598/79 LYHER ITB-402-0798/79 LYHER ITB-402-2098/79 9 others LYHER ITB-402-2598/79 LYHER ITB-402-4098/79 LYHER ITYP-402-0198/79 LYHER ITYP-402-0298/79 LYHER ITYP-402-0598/79 LYHER ITYP-402-0798/79 LYHER ITYP-402-2098/79 LYHER ITYP-402-2598/79 LYHER ITYP-402-4098/79	– 98/79	office@lyher.com EUDAMED record Report an error
Vivachek FDA EU representative : Lotus NL B.V. (Netherlands)	China	Campylobacter Rapid Test VICB98/79 Gonorrhea Rapid Test VIGO98/79 Legionella Rapid Test VILEG98/79 Leptospira IgG/IgM Rapid Test VILP98/79 Leptospira IgG/IgM Rapid Test VILP-42698/79 8 others Lyme IgG/IgM Rapid Test VILY98/79 S.pneumoniae/L.pneumoohila Combo Rapid Test VSL98/79 Tetanus Rapid Test VITE98/79 Tuberculosis (TB) Rapid Test VITB98/79 Tuberculosis IgG/IgM Rapid Test VITB98/79 Tuberculosis IgG/IgM Rapid Test VITB-40298/79 Typhoid Ag Rapid Test VITYg98/79 Typhoid IgG/IgM Rapid Test VITYb98/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Clongene FDA EU representative : HUMISS TRADING S. L. (Spain) and 1 other	China	Brucellosis IgG/IgM Rapid Test IBRU4211, IBRU421298/79 Leptospira IgG/IgM Rapid Test ILEP4211, ILEP421298/79 M. tuberculosis Antigen Rapid Test ITBGa002 ITBGa00898/79 Mycoplasma pneumoniae Antigen Rapid Test IMPGp002 IMPGp00898/79 Mycoplasma Pneumoniae IgM Rapid Test IMP4001, IMP400298/79 7 others S.Typhi Antigen Rapid Test ISTG600298/79 Scrub Typhus IgG/IgM Rapid Test / Rickettsia IgG/IgM Rapid Test ISTA421298/79 Tuberculosis Rapid Test ITB4001, ITB400298/79 Typhoid IgG/IgM Rapid Test (S/P) ISTB321298/79 Typhoid IgG/IgM Rapid Test Cassette (WB/S/P) ISTB421298/79 Vibrio Cholerae O1 Antigen Rapid Test IVCA600298/79 Vibrio Cholerae O1/O139 Antigen Rapid Test Cassette (Feces) IVC621298/79	– 98/79	Website marketing@clongene.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Crypto/Giardia combo Test98/79 Cryptococcus Rapid Test98/79 Cryptosporidium Test Crypto-F2398/79 Device A438711252 refs Device A43910125 6 others Device A4B31011 Device A4B370125 Giardia lamblia Test GL-F2398/79 Rickettsia Test RICK-W2398/79 S. pneumoniae Rapid Test Device (Urine) SPN-U2398/79 Tuberculosis Rapid Test Device (Whole Blood/Serum/Plasma)98/79	C IVDR, 98/79	Website contact@diareagent.com EUDAMED record Report an error
Neo-nostics (Suzhou) Bioengineering EU representative : Medunion S.L. (Spain)	China	Brucella Antibody Test Kit(Serum/plasma/whole blood) BRU004898/79 E.coli O157 Test Kit(Feces) ECO005798/79 H.pylori Antibody Test Kit(Serum/plasma/whole blood) HPB002098/79 H.pylori Antigen Test Kit(Feces) HPG002198/79 Leptospira lgG/lgM Test Kit(Serum/plasma/whole blood) LEP013098/79 6 others Scrub Typhus IgG/IgM Test Kit(Serum/plasma/whole blood) SCR001398/79 Shigella Antigen Test Kit(Feces) SHI018098/79 Shigella lgG/lgM Test Kit(Serum/plasma/whole blood) SHI017998/79 Syphilis Antibody Test Kit(Serum/plasma/whole blood) SYP005298/79 Typhoid Antigen Test Kit(Feces) TYP008698/79 Typhoid IgG/IgM Test Kit(Serum/plasma/whole blood) TYP008598/79	– 98/79	EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	CAMPYLOBACTER HIZLI TEST KİTİ CHOLERA RAPID TEST KIT LEPTOSPIRA RAPID TEST KIT VISD081 MYCOPLASMA GENITALIUM AB HIZLI TEST KİTİ MYCOPLASMA PNEUMONIAE AB HIZLI TEST KİTİ 6 others MYCOPLASMA PNEUMONIAE AG HIZLI TEST KİTİ MYCOPLASMA RAPID TEST KIT VISD047 SALMONELLA S. RAPID TEST KIT VISD069 TETANUS IGG RAPID TEST KIT VISD067 TYPHOID AB RAPID TEST KIT TÜBERKÜLOZ HIZLI TEST KİTİ	B, C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Rapid Leptospira IgG/IgM Combo Test 1O23C2-1-EU, 1O23C2-25-EU98/79 Rapid Rickettsia IgG/IgM Combo Test Card 1O06C298/79 Rapid Salmonella typhi Antigen Test Card 1O09C298/79 Rapid Salmonella typhi IgG/IgM Duo Test Card 1O04C298/79 Rapid Salmonella typhi/paratyphi Antigen Duo Test 1O13C298/79 4 others Rapid Tuberculosis Test Card-Serum 1O01C198/79 Rapid V. Cholerae O1 Test Strip 1O15S498/79 Rapid V.Cholerae O1/O139 Duo Test Card 1O17C498/79 Rapid V.Cholerae O139 Test Strip 1O16S498/79	– 98/79	Website EUDAMED record Report an error
Encode EU representative : Medunion S.L. (Spain)	China	Gonorrhea + Chlamydia Antigen Combo Test Cas-sette 1 Test/Kit98/79 Gonorrhea + Chlamydia Antigen Combo Test Cassette 10 Tests/Kit98/79 Gonorrhea + Chlamydia Antigen Combo Test Cassette 2 Tests/Kit98/79 Gonorrhea + Chlamydia Antigen Combo Test Cassette 20 Tests/Kit98/79 Gonorrhea + Chlamydia Antigen Combo Test Cassette 25 Tests/Kit98/79 4 others Gonorrhea + Chlamydia Antigen Combo Test Cassette 3 Tests/Kit98/79 Gonorrhea + Chlamydia Antigen Combo Test Cassette 40 Tests/Kit98/79 Gonorrhea + Chlamydia Antigen Combo Test Cassette 5 Tests/Kit98/79 SGC-52250 50 Tests/Kit98/79	– 98/79	Website EUDAMED record Report an error
nal von minden	Germany	NADAL® Campylobacter Test3 refs98/79 NADAL® E. coli O157 Test98/79 NADAL® Gonorrhea Test2 refs98/79 NADAL® Lyme Borreliosis IgG/IgM Test98/79 NADAL® Mycoplasma Test98/79 3 others NADAL® Salmonella spp. Test98/79 NADAL® Tetanus Test2 refs98/79 NADAL® Tuberculosis IgG/IgM Test98/79	– 98/79	Website info@nal-vonminden.com EUDAMED record Report an error
Human	Germany	HumaTex Febrile Antigens Brucella abortus98/79 HumaTex Febrile Antigens Multiscreening Kit98/79 HumaTex Febrile Antigens Salmonella Kit98/79 HumaTex Febrile Antigens Salmonella paratyphi AH98/79 HumaTex Febrile Antigens Salmonella paratyphi BH98/79 2 others HumaTex Febrile Antigens Salmonella typhi H98/79 HumaTex Febrile Antigens Salmonella typhi O98/79	– 98/79	Website EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	Bordetella Pertussis (BP) Antigen Detection Kit98/79 Candidiasis Antigen Test Kit98/79 Gardneralla Vaginalis Rapid Test98/79 Neisseria gonorrhoeae Antigen Test Kit Ir01998/79 Salmonella Typhi Ag Test Kit98/79 2 others Treponema pallidum Antibody Test Kit Ir01698/79 Typhoid Ab IgM/IgG Test Kit98/79	– 98/79	EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	1 test/kit3 refs98/79 25 tests/kit3 refs98/79 GeneSign Brucella IgG/IgM Rapid Test 1 test/kit98/79 GeneSign Brucella IgG/IgM Rapid Test 25 tests/kit98/79 GeneSign TB IgG/IgM Rapid Test 1 test/kit98/79 1 other GeneSign TB IgG/IgM Rapid Test 25 tests/kit98/79	– 98/79	info@genesignbio.com EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands)	China	Campylobacter Rapid Test GICB98/79 Campylobacter Test GICB98/79 Gonorrhea Rapid Test GIGON98/79 Leptospira IgG/IgM Rapid Test GILEPb98/79 Lyme IgG/IgM Rapid Test GILygm98/79 1 other S.pneumoniae/L.pneumoohila Combo Rapid Test GISL98/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Hangzhou Genesis Biodetection Biocontrol FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	B. pertussis Antigen Rapid Test P21110698/79 Campylobacter Antigen Rapid Test P22110798/79 Leptospira IgG/IgM Rapid Test P23111998/79 Shigella Antigen Rapid Test P22111098/79 Vibrio cholerae O1/O139 Antigen Rapid Test98/79 2 others Salmonella Typhi Antigen Rapid Test98/79 (no longer marketed) Salmonella Typhi IgG/IgM Rapid Test98/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany)	China	Accu-Tell® TB Cassette (Serum/Plasma)98/79 Accu-Tell® TB Cassette (Whole Blood/Serum/Plasma)98/79 Accu-Tell® TB Strip (Whole Blood/Serum/Plasma)98/79 Accu-Tell® Typhoid Cassette (Serum/Plasma)98/79 Accu-Tell® Typhoid Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	sales@accubiotech.com EUDAMED record Report an error
Avioq Bio-tech EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	1 Test/Kit98/79 20 Tests/Kit98/79 25 Tests/Kit98/79 40 Tests/Kit98/79 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Citest Diagnostics EU representative : VidaQuick Biotech S.L. (Spain)	Canada	Campylobacter Rapid Test Cassette (Feces) ICAM-60298/79 Gardnerella vaginalis Antigen Rapid Test (Vaginal Swab)98/79 Gonorrhea Rapid Test (Swab)98/79 Shigella Rapid Test Cassette (Feces) ISH-CT62598/79 Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test (Feces)98/79	– 98/79	ra02@citestdiagnostics.com EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other	China	Rightsign IMP-C8198/79 Rightsign ISP-C1198/79 Rightsign ITB-C3198/79 Rightsign ITB-C4198/79 Rightsign IVC-MC6298/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
Mpbio FDA EU representative : MP Biomedicals Germany GmbH (Germany)	Germany, Singapore	MP Diagnostics ASSURE TB Rapid Test98/79 Rapid V. cholerae O1 Test Card98/79 Rapid V. cholerae O1 Test Strip98/79 Rapid V.Cholerae O139 Test Card98/79 Rapid V.Cholerae O139 Test Strip98/79	– 98/79	Website EUDAMED record Report an error
Phasescientific FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Hong Kong SAR China	INDICAID™ Mycoplasma Pneumoniae (MP) Rapid Antigen Test98/79 INDICAID™ Mycoplasma Pneumoniae (MP) Rapid IgM Antibody Test98/79 INDICAID™ Ureaplasma Urealyticum Rapid Antibody Test98/79 INDICAID™Mycobacterium Tuberculosis Rapid IgG Antibody Test98/79 INDICAID™Neisseria Gonorrhoeae (NGH) Rapid Antigen Test98/79	– 98/79	Website info@phasesci.com EUDAMED record Report an error
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Bioline™ Tsutsugamushi 18FK1098/79 Bioline™ Tsutsugamushi 18FK1198/79 SD BIOLINE Tsutsugamushi 18FK1098/79 SD BIOLINE Tsutsugamushi 18FK1198/79	– 98/79	Website EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Sungo Cert GmbH (Germany)	China	(NGH) Neisseria Gonorrhoeae Test Strip & Cassette98/79 H.Pylori Ab Test Cassette AB60-1198/79 H.Pylori Ag Test Cassette AB61-2098/79 TP Syphilis Test Cassette98/79	– 98/79	EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Brucella Antigen Rapid Test H1429-21W98/79 Human Brucella IgM/IgG Antibody Rapid Test H1428-21W98/79 Tsutsugamushi IgM Antibody Rapid Test98/79 Vibrio Cholerae O1/O139 Antigen Rapid Test98/79	– 98/79	Website EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany)	China	Gardnerella Vaginalis Antigen Rapid Test Mycoplasma pneumoniae Antigen Rapid Test MP-502b98/79 Salmonella Typhi Antigen Test98/79 TYP-422a98/79	B IVDR, 98/79	Website EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain)	China	Gonorrhea Antigen Rapid Test Kit(Lateral Chromatography) 1 Test/Kit98/79 Gonorrhea Antigen Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 Gonorrhea Antigen Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	Mycoplasma Pneumoniae IgM Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79 Typhoid Rapid Test Kit（Colloidal Gold） 20 tests / kit98/79 Typhoid Rapid Test Kit（Colloidal Gold） 25 tests / kit98/79	– 98/79	EUDAMED record Report an error
Biomaxima	Poland	Campylobacter kasetki 20 szt. Crypto + Giardia kasetki 20 szt. Giardia kasetki 20 szt.2 refs	B IVDR	Website info@biomaxima.com EUDAMED record Report an error
Certest	Spain	CerTest Campylobacter3 refs Certest ResisCheck® Carbapenemases CerTest S. pneumoniae+Legionella	B, C IVDR	Website quality@certest.es EUDAMED record Report an error
Core Technology FDA EU representative : Medunion S.L. (Spain)	China	Group A Streptococcus Ag Test Cassette98/79 Group B Streptococcus Ag test Cassette98/79 MP Ag Test Cassette98/79	– 98/79	EUDAMED record Report an error
Labnovation EU representative : MedNet EC-REP GmbH (Germany)	China	Candida Albicans/Trichomonas vaginalis Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Neisseria Gonorrhoeae Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Vibrio Cholerae O1/O139 Antigen Rapid Test kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	Website info@labnovation.com EUDAMED record Report an error
Nanjing Leading Medical Technology EU representative : Medunion S.L. (Spain)	China	1 Test/Box98/79 25 Tests/Box98/79 50 Tests/Box98/79	– 98/79	EUDAMED record Report an error
Aichek FDA EU representative : Medunion S.L. (Spain) and 1 other	China	Tuberculosis (TB) IgG/IgM Rapid Test98/79 Typhoid Antibody Rapid Test98/79	– 98/79	ra.rep@aichek.com EUDAMED record Report an error
Arkray FDA EU representative : Arazy Group GmbH (Germany)	India	Crystal 16IC101-50 Crystal® VC - O1	C IVDR	Website EUDAMED record Report an error
Jei Daniel (JD) Biotech EU representative : Medical Technology Promedt Consulting GmbH (Germany)	China	JDBiotech JGVAG0198/79 JDBiotech JGVAG0298/79	– 98/79	contact@jeidanielbiotech.com EUDAMED record Report an error
Loop Diagnostics	Spain	LoopReagent SEPTILOOP - LoopStrip2 refs	A, C IVDR	Website EUDAMED record Report an error
Operon FDA	Spain	SIMPLE Strep pneumo-Legio / STICK Strep pneumo-Legio 9.108.XXX.YY.ZZZ98/79 Simple/Stick Campylobacter 9.230.XXX.YY.ZZZ98/79	– 98/79	Website infoeudamed@operon.es EUDAMED record Report an error
Reagena	Finland	ReaScan+ C6 LYME IgG98/79 ReaScan+ LYME IgM/IgG Combo98/79	– 98/79	Website info@reagena.com EUDAMED record Report an error
Synthgene (Yixing) Health Technology EU representative : MedPath GmbH (Germany)	China	Typhoid Antigen Rapid Test Kit (Colloidal gold method)98/79 Typhoid IgG/IgM Rapid Test Kit (Colloidal gold method)98/79	– 98/79	sales@syngenebio.com EUDAMED record Report an error
Vitrosens	Türkiye	RapidFor™ Cholera O1/O139 Test Kit RapidFor™ VMD87TD98/79	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI Device:20 Test/Kit98/79 QINGLI Strip: 25Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Abon Biopharm(Hangzhou) EU representative : Medical Technology Promedt Consulting GmbH (Germany)	China	ITB-40298/79	– 98/79	EUDAMED record Report an error
Artronlab FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	Artron ONE STEP Tuberculosis Antibody (TB Ab) Test Cassette98/79	– 98/79	Website info@artronlab.com EUDAMED record Report an error
Cesna	Türkiye	LEPTOSPIRA HIZLI TEST KİTİ	B IVDR	Website info@cesna.com.tr EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany)	China	Gardnerella vaginalis Ag Rapid Test Kit98/79	– 98/79	office@guoke-medical.com EUDAMED record Report an error
Eurobio Scientific	France	Tetanos Quick Stick3 refs98/79	– 98/79	reglementaire@eurobio-scientific.com EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	25 tests/kit98/79	– 98/79	info@fanttest.com EUDAMED record Report an error
InTec PRODUCTS EU representative : QbD RepS BV (Belgium)	China	Rapid Anti-TB (Mycobacterium Tuberculosis) Test ITP090022 refs98/79	– 98/79	Website EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland)	China	StrongStep® Diagnostic Kit for Bacterial Vaginosis (PH-VALUE) 50 Tests/box98/79	– 98/79	Website sales@limingbio.com EUDAMED record Report an error
Lionex	Germany	LIODetect® TB-ST98/79	– 98/79	Website info@lionex.de EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Candida Albicans Antigen Test Kit(Immunofluorescence)98/79	– 98/79	EUDAMED record Report an error
Tauns EU representative : Emergo Europe B.V. (Netherlands)	Japan	Capilia TB-Neo 100T/Box2 refs	C IVDR	Website EUDAMED record Report an error
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş	Türkiye	Tuberculosis (TB) Test6 refs98/79	– 98/79	Website info@turklab.com.tr EUDAMED record Report an error
Vircell	Spain	VIRAPID® TULAREMIA VR00698/79	– 98/79	EUDAMED record Report an error
Xenta Biomedical Science FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	TB Specific Cellular Immune Response (TB-IGRA) Rapid Quantitative Test2 refs98/79	– 98/79	Website EUDAMED record Report an error
Zhejiang Wantaifu Biotechnology EU representative : OSEN GmbH (Germany)	China	Bio·Firm WI-GON-C71-2598/79	– 98/79	Website EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	Anaplasmosis Antibody Rapid Test98/79 (no longer marketed) Candida Albicans/Gardnerella Vaginalis /Trichomonas Vaginalis Combo Rapid Test（Swab）98/79 (no longer marketed) Ehrlichia Antibody Rapid Test98/79 (no longer marketed) Mycobacterium Tuberculosis Antibody Rapid Test98/79 (no longer marketed) Typhoid Antigen Rapid Test98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	China	24 tests/kit98/79 (no longer marketed) 96 tests/kit98/79 (no longer marketed) W-PLSA-4898/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.

Didn't find it?

Related categories