Manufacturer

Tongzhoubio

ChinaLegal entities : Hangzhou Tongzhou Biotechnology Co., Ltd.

Markets : Germany · Ireland · Spain · United States

Approvals : EU – class B · United States (FDA) – · class I, II

EU representative : VidaQuick Biotech S.L. (Spain)

26 categories, 183 models including 183 on the market, 1 country

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

Category	EMDN code	Registered models	Class	Contact
Bacteriology - RT & POC - other	W0105090199	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
Virology - RT & POC - other	W0105099099	Adenovirus Antigen Test Kit YI061-600298/79 Adenovirus pneumoniae Antigen Rapid Test I050-500298/79 Adenovirus Rapid Test I005-600298/79 Astrovirus Rapid Test I010-600298/79 Dengue IgG/IgM And NS1 Combo Rapid Test98/79 26 others Dengue IgG/IgM Rapid Test I027-400298/79 Dengue IgG/IgM Test Kit YI054-400298/79 Dengue/Zika/Chikungunya Combo Rapid Test I163-404598/79 Enterovirus Antigen Rapid Test I156-600298/79 EV71 IgM Rapid Test98/79 Hantavirus IgG/IgM Rapid Test I135-400298/79 HAV IgG/IgM Combo Rapid Test I083-402598/79 HAV IgM Rapid Test I082-400298/79 HEV IgG/IgM Rapid Test I043-300298/79 HMPV Rapid Test98/79 HPIV Rapid Test98/79 HPV Antigen Rapid Test T018-500298/79 Human Bocavirus Antigen Rapid Test I200-500298/79 Measles IgG/IgM Rapid Test I155-400298/79 Norovirus Rapid Test I007-600298/79 Rhinovirus Rapid Test I178-500298/79 Rotavirus and Adenovirus Combo Rapid Test Cup I008-602798/79 Rotavirus and Adenovirus Combo Rapid Test I008-602598/79 Rotavirus Rapid Test I006-600298/79 Varicella Zoster Virus IgM Rapid Test I131-400298/79 West Nile Virus IgG/IgM Rapid Test I158-400298/79 Zika Antigen Test Kit YI070-400298/79 Zika IgG/IgM and NS1 Combo Rapid Test98/79 Zika IgG/IgM Rapid Test I031-400298/79 Zika IgM Test Kit YI071-400298/79 Zika NS1 Rapid Test98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	Adenovirus&RSV Combo Rapid Test I055-502598/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test I056-503598/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Chikungunya and Dengue Combo Rapid Test I202-403598/79 18 others HSV 1/2 IgG Rapid Test (S/P)98/79 HSV 1/2 IgG Rapid Test (WB/S/P)98/79 HSV 1/2 IgG/IgM Combo Rapid Test2 refs98/79 HSV 1/2 IgG/IgM Rapid Test (Serum/Plasma)98/79 HSV 1/2 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgM Rapid Test (Serum/Plasma)98/79 HSV 1/2 IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 Multiplex Respiratory Virus Antigen Rapid Test I161-507598/79 Multiplex Respiratory Virus Antigen Rapid Test I161-5XX598/79 Norovirus, Rotavirus and Adenovirus Combo Rapid Test I009-603598/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Cup I011-604798/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test I011-604598/79 RSV&Influenza A+B Combo Rapid Test I054-502598/79 SARS-CoV-2 and M.pneumoniae IgG Combo Rapid Test98/79 SARS-CoV-2 and M.pneumoniae IgG/IgM Combo Rapid Test98/79 SARS-CoV-2 and RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test98/79	– 98/79	EUDAMED record Report an error
Controls infectious immunology - RT & POC	W0105094001	Adenovirus control HSCADE-D-L98/79 H. pylori Antibody control HSCHPB-L98/79 H. pylori Antigen control HSCHPG-D-L98/79 Influenza A+B control HSCFLAB-S98/79 Malaria P.f./Pan control HSCMPN-D98/79 7 others Mycoplasma pneumoniae Antigen control HSCMP-S98/79 Mycoplasma Pneumoniae IgG/IgM control HSCMPGM-L98/79 Mycoplasma Pneumoniae IgM control HSCMPM-L98/79 Rotavirus and Adenovirus control HSCRAC-D-L98/79 Rotavirus control HSCROT-D-L98/79 SARS-CoV-2/Influenza A+B/RSV control98/79 Syphilis control HSCSYP-L98/79	– 98/79	EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC	W0105090502	2019-nCoV IgG/IgM Rapid Test98/79 Coronavirus (SARS-CoV-2) Ag Self Test98/79 SARS-CoV-2 Antigen Test-Saliva98/79 SARS-CoV-2 Antigen Test2 refs98/79 SARS-CoV-2 IgG Rapid Test98/79 3 others SARS-CoV-2 Neutralization Antibody Rapid Test98/79 SARS-CoV-2 NPAb and NAb Combo Rapid Test98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test98/79	– 98/79	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	Cryptosporidium and Giardia Lamblia Combo Rapid Test I015-602598/79 Cryptosporidium Rapid Test I014-600298/79 Entamoeba histolytica Rapid Test I012-600298/79 Entamoeba/Giardia/Crypto Combo Rapid Test (3 Windows)98/79 Entamoeba/Giardia/Crypto Rapid Test (1 Window)98/79 3 others Filariasis IgG/IgM Rapid Test (Serum/Plasma)98/79 Filariasis IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 Giardia Lamblia Rapid Test I013-600298/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f. Rapid Test I039-400198/79 Malaria P.f. Rapid Test I039-400298/79 Malaria P.f./ Pan Rapid Test I040-400298/79 Malaria P.f./P.v. Rapid Test I041-400298/79 Malaria P.f./P.v./Pan Rapid Test I042-400298/79 1 other Malaria P.f./P.v./Pan Test Kit YI063-403598/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox RT & POC	W0105099008	Monkeypox Antibody Rapid Test I089-400298/79 Monkeypox Antigen Rapid Test I090-400298/79 Monkeypox Virus Antibody Test Kit YI067-400298/79 Monkeypox Virus Antigen Test Kit YI066-400298/79 Monkeypox Virus Real Time PCR-Kit98/79	– 98/79	EUDAMED record Report an error
Viral antigen/antibody detection - other	W0105040699	Chikungunya IgG/IgM Rapid Test (Serum/Plasma) I026-300298/79 Chikungunya IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) I026-400298/79 Chikungunya IgG/IgM Test Kit YI064-400298/79 Mycoplasma pneumoniae and Influenza A+B Antigen Combo Rapid Test I154-502598/79 Rotavirus and Adenovirus Combo Rapid Test I008-N6025-252 refs	B IVDR, 98/79	EUDAMED record Report an error
Mononucleosis (ebv) - RT & POC	W0105099003	EBNA IgG Rapid Test I076-400298/79 EBV VCA and EBNA IgG Combo Rapid Test I077-402598/79 EBV VCA IgG Rapid Test I075-400298/79 MONO Rapid Test I049-400298/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	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	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test98/79 SARS-CoV-2 and Influenza A+B Antigen Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	FLU A+B Test Kit98/79 H1N1 Antigen Rapid Test2 refs98/79 Influenza A/B+H1N1 Combo Rapid Test98/79	– 98/79	EUDAMED record Report an error
Chagas	W0105050202	Chagas Rapid Test (Serum/Plasma) I025-300298/79 Chagas Rapid Test (Whole Blood/Serum/Plasma) I025-400298/79	– 98/79	EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	Clostridium Difficile GDH Test Kit YI062-600298/79 Clostridium difficile Toxin A/ toxin B Combo Test Kit YI010-602598/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	COVID-19 Antigen Test Kit98/79 COVID-19 S-RBD IgG Antibody Test Kit98/79	– 98/79	EUDAMED record Report an error
Legionella - RT & POC	W0105090108	Legionella pneumophila Rapid Test98/79 Legionella pneumophila Test Kit98/79	– 98/79	EUDAMED record Report an error
Strep. b - RT & POC	W0105090104	Strep B Rapid Test I004-500198/79 Strep B Rapid Test I004-500298/79	– 98/79	EUDAMED record Report an error
Strep. pneumoniae - RT & POC	W0105090109	Streptococcus pneumoniae Antigen Rapid Test98/79 Streptococcus pneumoniae Test Kit98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer Test Kit YI029-400298/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H.Pylori Antibody Rapid Test I021-N4002-253 refs	B IVDR	EUDAMED record Report an error
Haemoglobin (hb)	W0103010601	Hb Hemoglobin Test Strip O022-401198/79	– 98/79	EUDAMED record Report an error
Haemoglobin subtypes hba2, hbc, hbf, hbs, etc.(excl. hba1)	W0103010202	Sickle Cell Rapid Test O027-400298/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	IL-6 Test Kit98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	RSV Test Kit YI053-500298/79	– 98/79	EUDAMED record Report an error
Trichomonas	W0105050210	Trichomonas Vaginalis Rapid Test I085-500298/79	– 98/79	EUDAMED record Report an error

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