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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 2 of 6

Device	Model / Reference	Registries	Class	Status
Cryptococcus Rapid Test	/	EUDAMED	IVD General	Active
G6PD and Hemoglobin Biosensor Test Meter	GPHB-101	EUDAMED	Class A	Active
Fully Automatic Biochemistry Analyzer	AS-60C	EUDAMED	Class A	Active
Tuberculosis Rapid Test Device (Whole Blood/Serum/Plasma)	TB-W23	EUDAMED	IVD General	Active
COVID-19 Antigen Saliva Test Kit	COV-S35	EUDAMED	IVD General	Active
H. pylori Antigens Rapid Test	HP-F23	EUDAMED	IVD General	Active
Flu A/B Fia	FLU-S23F3	EUDAMED	IVD General	Active
Alpha Fetoprotein Chemiluminescence Immunoassay Test Kit	G200A08	EUDAMED	IVD General	Active
Total T4 FIA	TT4-W23F3	EUDAMED	IVD General	Active
Cystatin C FIA	CYSC-W23F3	EUDAMED	IVD General	Active
HbA1c FIA	HbA1c-W23F3	EUDAMED	IVD General	Active
H. pylori Antibodies Rapid Test	HP-W23	EUDAMED	IVD General	Active
Acetaminophen	ACE-U11, ACE-U23	EUDAMED	IVD General	Active
Rsv Fia	RSV-S23F3	EUDAMED	IVD General	Active
Vitamin D3 FIA	VD-W23F3	EUDAMED	IVD General	Active
Ckmb Fia	CKMB-W23F3	EUDAMED	IVD General	Active
Ecstasy Rapid Test	MDMA-U11, MDMA-U23	EUDAMED	IVD General	Active
Cannabinol Rapid Test	CBN-U11 CBN-U23	EUDAMED	IVD General	Active
Influenza A/B Rapid Test	FLU-S23M	EUDAMED	IVD General	Active
Methcathinone Rapid Test	MCAT-U11 MCAT-U23	EUDAMED	IVD General	Active
Cardiac Troponin I Rapid Test Device (Whole Blood/Serum/Plasma)	TRO-W23	EUDAMED	IVD General	Active
Micro-Albumin FIA	ALB-U23F3	EUDAMED	IVD General	Active
Morphine Rapid Test	MOR-U11, MOR-U23	EUDAMED	IVD General	Active
Giardia lamblia Rapid Test	Format (cassette): A4B910	EUDAMED	Class B	Active
Free Thyroid Hormone Chemiluminescence Immunoassay Test Kit	G016A08	EUDAMED	IVD General	Active
Hepatitis A Virus IgG/IgM Test Kit	HAV-W35M HAV-P23M	EUDAMED	IVD General	Active
Β2mg Fia	β2mg-W23F3	EUDAMED	IVD General	Active
Interleukin-6 FIA	IL6-W23F3	EUDAMED	IVD General	Active
Multiple Drugs Test Cup	MD-U618	EUDAMED	IVD General	Active
Transferrin and Fecal Occult Blood and Haptoglobinhemoglobin Combo Test Device	MT-F43M002	EUDAMED	IVD General	Active
Triiodothyronine Chemiluminescence Immunoassay Test Kit	/	EUDAMED	IVD General	Active
HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)	HIV-W23	EUDAMED	IVD Annex II List A	Active
COVID-19 Neutralizing Antibody Rapid Test	COV-W23001	EUDAMED	IVD General	Active
Adenovirus FIA	ADV-F23F3	EUDAMED	IVD General	Active
Ferritin Chemiluminescence Immunoassay Test Kit	G209A08	EUDAMED	IVD General	Active
Strep A Rapid Test	STA-S23	EUDAMED	IVD General	Active
Typhoid Rapid Test	TYP-F23, TYP-W23	EUDAMED	IVD General	Active
7-Amino clonazepam Rapid Test	7-ACL-U11 7-ACL-U23	EUDAMED	IVD General	Active
H. pylori Antibody FIA	HP-W23F3	EUDAMED	IVD General	Active
sST2 FIA	sST2-W23F3	EUDAMED	IVD General	Active
H. pylori Antibody Rapid Test	Format (cassette): A4A411;Format (strip): A4A410	EUDAMED	Class B	Active
COVID-19&Influenza A/B Antigen combo Test	Format (cassette): A494301;Format (pen): A47660	EUDAMED	Class B	Active
Cotinine Rapid Test	COT-U11, COT-U23	EUDAMED	IVD General	Active
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests	K180349	FDA 510(k)	Class II	Active
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests	K201630	FDA 510(k)	Class II	Active
AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)	K153465	FDA 510(k)	Class II	Active
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests	K181768	FDA 510(k)	Class II	Active
AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)	K161044	FDA 510(k)	Class II	Active
AssureTech Panel Dip Test, AssureTech Quick Cup Test	K170049	FDA 510(k)	Class II	Active
COVID-19 & Influenza A/B Antigen Nasal Test Kit	MI-S33001H	EUDAMED	IVD devices for self-testing	Active

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