Is this your brand? Sign in to claim ownership.

Taizhou Cowingene Biotech Co.,Ltd.

China·CN-MF-000042619

Last updated June 8, 2026

About

Cowingene is a global innovation leader in molecular POCT in vitro diagnostics, provid fast and reliable diagnostic solutions to improve human health worldwide. They offer PCR kits, extraction kits and molecular POCT for human papillomavirus ( HPV ), sexually transmitted, respiratory, tuberculosis, gastrointestinal and other infections.

From the manufacturer's own website. Source

Information

Country: China
Address: NO.28, Xinlin Road, Taizhou, Jiangsu, China
Website: www.cowingene.com
LinkedIn: linkedin.com/company/taizhou-cowingene-biotechnology-co-ltd
Facebook: facebook.com/profile.php
Email: [email protected]
Phone: +860523-88350768 (from company website)
PRRC Contact: Dan Zhang
EUDAMED SRN: CN-MF-000042619
FDA FEI Number: —
DUNS Number: —

Catalogue (45)

Device	Model / Reference	Registries	Class	Status
Cowingene Mycoplasma Genitalium and Mycoplasma Hominis Detection Kit	ST12021X, ST12022X, ST12023W	EUDAMED	IVD General	Active
Cowingene Group B Streptococcus Detection Kit	ST06011X, ST06012X, ST06013W	EUDAMED	IVD General	Active
Cowingene Parvovirus B19 Detection Kit	NI09021X, NI09022X, NI09023W	EUDAMED	IVD General	Active
Cowingene Sample Collection Kit	CW03021Q	EUDAMED	Class A	Active
Cowingene HPV Genotyping Pro Detection Kit	HP14025V, HP14025Y	EUDAMED	IVD General	Active
Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit	ST01021V, ST01022U	EUDAMED	IVD General	Active
Cowingene Human Leukocyte Antigen B27 Detection Kit	HG01021X, HG01022X, HG01023W	EUDAMED	IVD General	Active
Cowingene DNA/RNA Extraction Kit	CW05021X	EUDAMED	Class A	Active
NATPure System	CW11022Q	EUDAMED	Class A	Active
Cowingene Monkeypox Virus Detection Kit	ST07011X, ST07012X, ST07013W	EUDAMED	IVD General	Active
SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography)	MY01029Q1, MY01029Q2	EUDAMED	IVD General	Active
Cowingene Dengue Virus, Zika Virus and Chikungunya Virus Detection Kit	FE01021X, FE01022X, FE01023W	EUDAMED	IVD General	Active
Cowingene Sample Collection Kit	CW04021Q	EUDAMED	Class A	Active
Cowingene HPV 15 Genotyping Detection Kit	HP03021V, HP03022U	EUDAMED	IVD General	Active
Cowingene Sample Release Reagent	CW02021Z	EUDAMED	Class A	Active
Cowingene Influenza A/B and RSV Detection Kit	RP03021X, RP03022X, RP03023W	EUDAMED	IVD General	Active
Cowingene Dengue Virus I/II/III/IV Detection Kit	FE02021X, FE02022X, FE02023W	EUDAMED	IVD General	Active
Cowingene Viral DNA/RNA Column	CW10021Y	EUDAMED	Class A	Active
Cowingene Respiratory Pathogen Panel 21 Detection Kit	RP23021V	EUDAMED	IVD General	Active
NATBox System	CW07023Q	EUDAMED	Class A	Active
Cowingene HPV 15 E6/E7 Gene mRNA Detection Kit	HP05021X, HP05022X	EUDAMED	IVD General	Active
Cowingene Respiratory Pathogen Panel Detection Kit	RP13021W, RP13022S, RP14021W, RP16023P, RP19023P RP14022U,	EUDAMED	IVD General	Active
Cowingene HPV 16/18/45 Detection Kit	HP10023W	EUDAMED	IVD General	Active
SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method)	MY02029Q	EUDAMED	IVD General	Active
Cowingene STI Multiplex Detection Kit	ST11021V, ST11022U, ST13021W, ST13022U, ST14021X, ST14022X, ST14023W, ST15023P	EUDAMED	IVD General	Active
Cowingene Dengue Virus Detection Kit	FE08021X, FE08021X, FE08023W	EUDAMED	IVD General	Active
Cowingene HPV (2+12) Detection Kit	HP02021X, HP02022X, HP02023W	EUDAMED	IVD General	Active
Cowingene HPV 6/11 Detection Kit	HP11021X, HP11023W	EUDAMED	IVD General	Active
Cowingene Varicella-Zoster Virus (VZV) Detection Kit	NI03021X, NI03022X, NI03023W	EUDAMED	IVD General	Active
Cowingene Sample Collection Kit	CW08021Q	EUDAMED	Class A	Active
Cowingene Epstein-Barr Virus (EBV) Detection Kit	NI02021X, NI02022X, NI02023W	EUDAMED	IVD General	Active
Cowingene Herpes Simplex Virus 1/2 Detection Kit	ST05011X, ST05012X, ST05013W	EUDAMED	IVD General	Active
Cowingene SARS-CoV-2 & Influenza A/B Detection Kit	RP11021X, RP11022X, RP11023W	EUDAMED	IVD General	Active
Cowingene MRSA/SA Detection Kit	HG06021X, HG06022X, HG06023W	EUDAMED	IVD General	Active
Cowingene Respiratory Pathogen Panel Pro Detection Kit	RP26021V, RP26021Y, RP26021V-1, RP26021Y-1, RP26022U, RP26022X, RP26022U-1, RP26022X-1	EUDAMED	IVD General	Active
Cowingene HPV 28 Genotyping Detection Kit	HP04021V, HP04022S	EUDAMED	IVD General	Active
Cowingene Diarrhea Virus Panel 6 Detection Kit	GI05021W	EUDAMED	IVD General	Active
Cowingene Enterovirus Universal, EV71 and CoxA16 Detection Kit	GI04021X, GI04022X, GI04023W	EUDAMED	IVD General	Active
Cowingene Monkeypox Virus Typing Detection Kit	ST08011X, ST08012X, ST08013W	EUDAMED	IVD General	Active
Cowingene Sample Diluent Reagent	CW09021W	EUDAMED	Class A	Active
Cowingene HPV (2+16) Detection Kit	HP01021X, HP01022X, HP01023W	EUDAMED	IVD General	Active
Cowingene Mycobacterium Tuberculosis Detection Kit	TB01021X, TB01022X, TB01023W	EUDAMED	IVD General	Active
Cowingene HPV Genotyping Detection Kit	HP12021X, HP13021V	EUDAMED	IVD General	Active
Cowingene MTB and NTM Detection Kit	TB02021X, TB02022X, TB02023W	EUDAMED	IVD General	Active
Cwingene STI Multiplex Pro Detection Kit	ST170(21V, 21Y, 21V-1, 21Y-1, 21V-2, 21Y-2, 21V-3, 21Y-3, 22U, 22X, 22U-1, 22X-1, 22U-2, 22X-2, 22U-3, 22X-3)	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

MedPath GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.