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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 1 of 6

Device	Model / Reference	Registries	Class	Status
Multi-functional MonitorⅠ	MSE-100	EUDAMED	Class A	Active
Multi-drug Saliva Test Stick	MD-S32~MD-S316	EUDAMED	IVD General	Active
Portable Coagulation Analyzer	AS-150C	EUDAMED	Class A	Active
H-Fabp Fia	H-FABP-W23F3	EUDAMED	IVD General	Active
Multi-drug Saliva Test Cup	MD-S42~MD-W415	EUDAMED	IVD General	Active
Fully Automatic Chemiluminescence analyzer	CLI1000X	EUDAMED	Class A	Active
Multi-drug Single-line Urine Test Device	MD-U42~MD-U415	EUDAMED	IVD General	Active
Multi-drug Single-line Saliva Test Device	MD-S42~MD-S415	EUDAMED	IVD General	Active
High Level Ferritin	/	EUDAMED	IVD General	Active
G6PD Biosensor Test Meter	G6PD-101	EUDAMED	Class A	Active
Cryptosporidium Test	Crypto-F23	EUDAMED	IVD General	Active
Transferrin Rapid Test	/	EUDAMED	IVD General	Active
6-Monoacetylmorphine Rapid Test	/	EUDAMED	IVD General	Active
Calprotectin FIA	CPT-F23F	EUDAMED	IVD General	Active
Normal Ferritin	/	EUDAMED	IVD General	Active
Cholesterol Test Device and Cholesterol Meter	Meter: CML-101 Device: MLS-101	EUDAMED	IVD General	Active
Hbhp (fob + Hbhp)	MT-F43M002	EUDAMED	IVD General	Active
LH Ovulation Rapid Tests	/	EUDAMED	IVD devices for self-testing	Active
Cardiac Marker Combo Rapid Test Device and Fluorescent Immunoassay Reader	CMC-W23F	EUDAMED	IVD General	Active
Automatic Chemiluminesence Immunoanalyzer	CLI1000	EUDAMED	Class A	Active
Colloidal Gold Test Analyzer	ACG1000	EUDAMED	Class A	Active
S. pneumoniae Rapid Test Device (Urine)	SPN-U23	EUDAMED	IVD General	Active
Multi-drug Saliva Test Kit	MD-S32~MD-S312	EUDAMED	IVD General	Active
Fluorescence Immunoassay Analyzer	AFI 6100B	EUDAMED	Class A	Active
Multi-functional Monitor	MSE-101	EUDAMED	Class A	Active
Colloidal Immunoassay Analyzer	ADT100	EUDAMED	Class A	Active
Lactate Test Meter	LAC-101	EUDAMED	Class A	Active
Zika IgG/IgM Rapid Test	ZIKA-W23M	EUDAMED	IVD General	Active
Chagas Antibody Rapid Test	CHA-W23	EUDAMED	IVD General	Active
Saliva Collection System	CS-S01，CS-S02	EUDAMED	Class A	Active
Legionella Antigen Rapid Test Device (Urine)	LEG-U23	EUDAMED	IVD General	Active
Hemoglobin Test Meter	AS-XH-02	EUDAMED	Class A	Active
Zika NS1 Antigen Rapid Test	ZIKA-NS1-W23	EUDAMED	IVD General	Active
Chikungunya IgG/IgM Rapid Test	CHKV-W23	EUDAMED	IVD General	Active
Cardiac Marker Rapid Test device and Immunoassay Reader	CMC-W23	EUDAMED	IVD General	Active
Zolpidem ZOL Rapid Test Device (Urine)	ZOL-U23	EUDAMED	IVD General	Active
Methylphenidate Rapid Test	/	EUDAMED	IVD General	Active
Ethylglucuronide (ETG) Rapid Test Device (Urine)	ETG-U23	EUDAMED	IVD General	Active
Multi-drug Single-line Whole Blood Test Device	MD-W42~MD-W415	EUDAMED	IVD General	Active
Blood Glucose and β-Ketone Test Meter	69528048C9040002X	EUDAMED	Class A	Active
Adenovirus Rapid Test	/	EUDAMED	IVD General	Active
Blood Glucose and Uric Acid and Total Cholesterol Test Meter	GUC-101	EUDAMED	Class A	Active
Handheld DOA Reader	ADT3000	EUDAMED	Class A	Active
Rickettsia Test	RICK-W23	EUDAMED	IVD General	Active
Semi-Automatic Fluorescence Immunassay Analyzer	AFI 5300	EUDAMED	Class A	Active
Handheld DOA Reader	ADT2000	EUDAMED	Class A	Active
Giardia lamblia Test	GL-F23	EUDAMED	IVD General	Active
Fluorescence Immunoassay Analyzer	TFL1000	EUDAMED	Class A	Active
Handheld DOA Reader	ADT2000	EUDAMED	Class A	Active
K2 Synthetic Marijuana Rapid Test	/	EUDAMED	IVD General	Active

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