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ASSURE TECH. (HANGZHOU) CO., LTD.

China·CN-MF-000002170

Last updated September 17, 2026

Information

Country: China
Address: Moganshan Road, Gongshu District, Building 4, No. 1418-50, Hangzhou, Zhejiang, China
Website: www.diareagent.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +(86)571-81022698
PRRC Contact: Allen Chen
EUDAMED SRN: CN-MF-000002170
FDA FEI Number: 3009585529
DUNS Number: —

Catalogue (297)

Page 4 of 6

Device	Model / Reference	Registries	Class	Status
Uric Acid Test Strips	C903005	EUDAMED	IVD General	Active
Fob Fia	FOB-F23F3	EUDAMED	IVD General	Active
Mycoplasma pneumoniae Antigen Rapid Test	MP-S23	EUDAMED	IVD General	Active
Prolactin FIA	PRL-W23F3	EUDAMED	IVD General	Active
Lactoferrin Rapid Test	LF-F23	EUDAMED	IVD General	Active
Rotavirus FIA	ROTA-F23F3	EUDAMED	IVD General	Active
6-Acetylmorphine FIA	ACE-H23F3	EUDAMED	IVD General	Active
Zaleplon Rapid Test	ZAL-U11 ZAL-U23	EUDAMED	IVD General	Active
Ketamine FIA	KET-H23F3	EUDAMED	IVD General	Active
Urine Multi-constituent Rapid Test	URS-12T	EUDAMED	IVD General	Active
Sta Fia	STA-S23F3	EUDAMED	IVD General	Active
C. difficile GDH Rapid Test	GDH-F23	EUDAMED	IVD General	Active
COVID-19 Antigen Rapid Test Device	COV-S23	EUDAMED	IVD General	Active
Phencyclidine Rapid Test	PCP-U11, PCP-U23	EUDAMED	IVD General	Active
Malaria P.f/Pan Rapid Test	Mal-W11M Mal-W23M	EUDAMED	IVD General	Active
Carbohydrate Antigen 19-9 FIA	CA199-W23F3	EUDAMED	IVD General	Active
Rotavirus Antigen Rapid Test	A49930	EUDAMED	Class B	Active
Fecal Occult Blood Buffer	FOB-B001	EUDAMED	Class A	Active
Opiate Rapid Test	OPI-U11, OPI-U23	EUDAMED	IVD General	Active
Cocaine FIA	COC-H23F3	EUDAMED	IVD General	Active
Adenovirus Antigen Feces Rapid Test	A49830	EUDAMED	Class B	Active
Campylobacter Rapid Test	CAM-F23	EUDAMED	IVD General	Active
Benzodiazepine Rapid Test	BZO-U11 BZO-U23	EUDAMED	IVD General	Active
Afp Fia	AFP-W23F3	EUDAMED	IVD General	Active
COVID-19 IgG Test Kit	COV-W35	EUDAMED	IVD General	Active
Ethyl glucuronide	ETG-U11, ETG-U23	EUDAMED	IVD General	Active
Cea Fia	CEA-W23F3	EUDAMED	IVD General	Active
Influenza A/B&ADV Antigen combo Test	Format (cassette): A4D330;Format (pen): A4D360	EUDAMED	Class B	Active
SARS-CoV-2 Antigen Rapid Tests for Self-Testing	COV-S23004H/COV-S23006H	EUDAMED	IVD devices for self-testing	Active
Strep B Rapid Test	STB-S23	EUDAMED	IVD General	Active
Free Triiodothyronine Chemiluminescence Immunoassay Test Kit	G015A08	EUDAMED	IVD General	Active
Norovirus FIA	NOV-F23F3	EUDAMED	IVD General	Active
Pct Fia	PCT-W23F3	EUDAMED	IVD General	Active
Blood Glucose Test Strips	C901005	EUDAMED	IVD General	Active
Multi-dip Drugs Test	MD-U516	EUDAMED	IVD General	Active
Growth Stimulation Expressed Gene 2 Chemiluminescence Immunoassay Test Kit	G022A08	EUDAMED	IVD General	Active
Cardiac Troponin I Rapid Test	TRO-W23	EUDAMED	IVD General	Active
Shigella Rapid Test	SGL-f23	EUDAMED	IVD General	Active
Mephedrone Rapid Test	MEP-U11 MEP-U23	EUDAMED	IVD General	Active
6-Monoacetylmorphine	MAM-U11 MAM-U23	EUDAMED	IVD General	Active
Benzodiazepine FIA	BZO-H23F3	EUDAMED	IVD General	Active
Free Triiodothyronine (fT3) FIA	FT3-W23F3	EUDAMED	IVD General	Active
Thyroid Stimulating Hormone FIA	TSH-W23F3	EUDAMED	IVD General	Active
Adv Fia	ADV-S23F3	EUDAMED	IVD General	Active
Universal Transport Medium	F404D07	EUDAMED	IVD General	Active
Thyroglobulin Chemiluminescence Immunoassay Test Kit	/	EUDAMED	IVD General	Active
Gabapentin Rapid Test	GAB-U11 GAB-U23	EUDAMED	IVD General	Active
Rotavirus/Adenovirus/Norovirus/Astrovirus Combo Test	MI-F44001	EUDAMED	IVD General	Active
Cholera O1 Antigen Fecal Test Kit	VCO1-F23	EUDAMED	IVD General	Active
Myoglobin Rapid Test	MYO-W23	EUDAMED	IVD General	Active

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Assure Tech. (hangzhou) Co., Ltd. US