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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 6 of 6

Device	Model / Reference	Registries	Class	Status
Syphilis FIA	SYP-W23F3	EUDAMED	IVD General	Active
Methadone Rapid Test	MTD-U11, MTD-U23	EUDAMED	IVD General	Active
Respiratory Syncytial Virus Antigen Rapid Test	A46210	EUDAMED	Class B	Active
E. coli O157 Rapid Test	ECO-F23	EUDAMED	IVD General	Active
C-Reactive Protein Rapid Test	CRP-W23M CRP-W35M	EUDAMED	IVD General	Active
COVID-19&Influenza A/B&RSV&ADV&MP Antigen combo Test	Format (cassette): A49230;Format (pen): A4D560	EUDAMED	Class B	Active
Carbohydrate Antigen 125 FIA	CA125-W23F3	EUDAMED	IVD General	Active
K3 Synthetic Cannabinoids Rapid Test	K3-U23	EUDAMED	IVD General	Active
Squamous Cell Carcinoma Antigen Chemiluminescence Immunoassay Test Kit	G216A08	EUDAMED	IVD General	Active
Methylphenidate	MPD-U11 MPD-U23	EUDAMED	IVD General	Active
α-pvp Rapid Test	APVP-U11 APVP-U23	EUDAMED	IVD General	Active
Cathine Rapid Test	CAT-U23	EUDAMED	IVD General	Active
H. pylori Antigen Rapid Test	A4A412	EUDAMED	Class B	Active
E. histolytica & Giardia lamblia & Crypto Combo Rapid Test Kit	MI-F43001	EUDAMED	IVD General	Active
Adenovirus Antigen Nasal Rapid Test	A464101	EUDAMED	Class B	Active
Pgi/Pgii Fia	MI-W22M001F3	EUDAMED	IVD General	Active
C. difficile GDH FIA	GDH-F23F3	EUDAMED	IVD General	Active
Methamphetamine (MET) Chemiluminescence Immunoassay Test Kit	G301A08	EUDAMED	IVD General	Active
Thyroid Stimulating Hormone Chemiluminescence Immunoassay Test Kit	G019A08	EUDAMED	IVD General	Active
Gastrin-17 Chemiluminescence Immunoassay Test Kit	G210A08	EUDAMED	IVD General	Active
Thyroid Stimulating Hormone Test	TSH-W23	EUDAMED	IVD General	Active
K4 Synthetic Cannabinoids Rapid Test	K4-U23	EUDAMED	IVD General	Active
Kratom (Mitragyna) Rapid Test	KAR-U11 KAR-U23	EUDAMED	IVD General	Active
Digital Pregnancy Tests	HCG-U35Da	EUDAMED	IVD devices for self-testing	Active
Mdma Fia	MDMA-H23F3	EUDAMED	IVD General	Active
Multi-line Drugs Test	MD-U415	EUDAMED	IVD General	Active
Total T3 FIA	TT3-W23F3	EUDAMED	IVD General	Active
Amphetamine Rapid Test	AMP-U11 AMP-U23	EUDAMED	IVD General	Active
Malaria P.f Rapid Test	Mal pf-W11M ,Mal pf-W23M	EUDAMED	IVD General	Active
COVID-19& Influenza A/B& RSV Antigen Combo Test	Format (cassette): A49810;Format (pen): A47760	EUDAMED	Class B	Active
Faecal Occult Blood Fecal Test Kit	FOB-F11 FOB-F23 FOB-F43	EUDAMED	IVD General	Active
Zopiclone Rapid Test	ZOP-U11 ZOP-U23	EUDAMED	IVD General	Active
β2-microglobulin Chemiluminescence Immunoassay Test Kit	G217A08	EUDAMED	IVD General	Active
Oxycodone Rapid Test	OXY-U11 OXY-U23	EUDAMED	IVD General	Active
H. pylori Antigens Rapid Test	HP-F23	EUDAMED	IVD General	Active
Astrovirus Test	ASV-F23	EUDAMED	IVD General	Active
H. pylori Antibodies Rapid Test	HP-P11 HP-P23 HP-W11 HP-W23	EUDAMED	IVD General	Active
Vitamin B12 FIA	VB12-W23F3	EUDAMED	IVD General	Active
Urine Adulteration Test	URL-U12	EUDAMED	IVD General	Active
Cardiac Markers Combo Rapid Test	CMC-W23M	EUDAMED	IVD General	Active
Carfentanyl Rapid Test	CFYL-U11 CFYL-U23	EUDAMED	IVD General	Active
Blood Cholesterol Monitoring Systems (Blood Cholesterol Meter, Test Strip)	CML-101,MLS-101	EUDAMED	IVD devices for self-testing	Active
Rotavirus-Adenovirus-Norovirus Combo Test	A4A130	EUDAMED	Class B	Active
Cocaine Rapid Test	COC-U11 COC-U23	EUDAMED	IVD General	Active
Tricyclic Antidepressant Rapid Test	TCA-U11 TCA-U23	EUDAMED	IVD General	Active
Multiple Drugs Saliva Test Kit	MD-S322	EUDAMED	IVD General	Active
H. pylori Antigen FIA	HP-F23F3	EUDAMED	IVD General	Active

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