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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 5 of 6

Device	Model / Reference	Registries	Class	Status
Rotavirus-Adenovirus-Astrovirus-Norovirus Combo Test	A4B630	EUDAMED	Class B	Active
Alprazolam Rapid Test	ALP-U11 ALP-U23	EUDAMED	IVD General	Active
COVID-19&Influenza A/B&RSV&ADV&MP&HMPV&HPIV Antigen combo Test	A4D830	EUDAMED	Class B	Active
Malaria pf/pv Rapid Test	Mal pf/pv-W11M Mal pf/pv-W23M	EUDAMED	IVD General	Active
Carcinoembryonic Antigen Chemiluminescence Immunoassay Test Kit	G207A08	EUDAMED	IVD General	Active
Vitamin B12 Chemiluminescence Immunoassay Test Kit	G703A08	EUDAMED	IVD General	Active
Blood Glucose Monitoring Systems (Blood Glucose Meter, Test Strip)	EG-101，EG-102，EGS-101	EUDAMED	IVD Annex II List B	Active
COVID-19 IgG Rapid Test	COV-W23002	EUDAMED	IVD General	Active
C. difficile Toxin A/B Rapid Test	A4A930	EUDAMED	Class B	Active
Trazodone Rapid Test	TZD-U11 TZD-U23	EUDAMED	IVD General	Active
Human Luteinizing Hormone Rapid Test	LH-U11 LH-U23 LH-U35	EUDAMED	IVD General	Active
Hemoglobin Test Strips and Hemoglobin Meter	AS-XH-02, HBM-W11	EUDAMED	IVD General	Active
Ferritin FIA	FRT-W23F3	EUDAMED	IVD General	Active
Barbiturate FIA	BAR-H23F3	EUDAMED	IVD General	Active
Morphine FIA	MOR-H23F3	EUDAMED	IVD General	Active
Buprenorphine Rapid Test	BUP-U11 BUP-U23	EUDAMED	IVD General	Active
K2 Synthetic marijuana	K2-U23	EUDAMED	IVD General	Active
COVID-19 Antigen Nasal Test Kit	COV-S35002H	EUDAMED	IVD devices for self-testing	Active
Dengue Rapid Test	A42870	EUDAMED	Class B	Active
Methamphetamine FIA	MET-H23F3	EUDAMED	IVD General	Active
Follicle-Stimulating Hormone Test	FSH-U11 FSH-U23 FSH-U35	EUDAMED	IVD General	Active
Tro-W23f3	TRO-W23F3	EUDAMED	IVD General	Active
Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Test Kit	G107A08	EUDAMED	IVD General	Active
Barbiturate Rapid Test	BAR-U11 BAR-U23	EUDAMED	IVD General	Active
COVID-19&Influenza A/B&RSV&ADV&MP&HMPV Antigen combo Test	A4D730	EUDAMED	Class B	Active
Gonorrhea Rapid Test	GON-S23	EUDAMED	IVD General	Active
Myoglobin Chemiluminescence Immunoassay Test Kit	G105A08	EUDAMED	IVD General	Active
COVID-19 Antigen Rapid Test	Format (cassette): A47915; Format (pen): A48410	EUDAMED	Class B	Active
Brucella Antiboby Test	BRU-W23	EUDAMED	IVD General	Active
Folate Chemiluminescence Immunoassay Test Kit	G702A08	EUDAMED	IVD General	Active
COVID-19 Antigen Saliva Test Kit	COV-S35	EUDAMED	IVD General	Active
Human Chorionic Gonadotropin Combo Rapid Test (20/20mIU)	Format(Strip):A02600;Format(Device):A03010	EUDAMED	Class B	Active
Ketamine (KET) Chemiluminescence Immunoassay Test Kit	G302A08	EUDAMED	IVD General	Active
Heart Fatty Acid Bindingprotein Chemiluminescence Immunoassay Test Kit	G103A08	EUDAMED	IVD General	Active
HAV IgM Rapid Test	A40310	EUDAMED	Class B	Active
EDDP Rapid Test	EDDP-U11 EDDP-U23	EUDAMED	IVD General	Active
D-Dimer FIA	DDM-W23F3	EUDAMED	IVD General	Active
Thyroid Hormone Chemiluminescence Immunoassay Test Kit	G012A08	EUDAMED	IVD General	Active
Norovirus GI+GII Rapid Test	A4B271	EUDAMED	Class B	Active
Morphine (MOR) Chemiluminescence Immunoassay Test Kit	G300A08	EUDAMED	IVD General	Active
Testosterone FIA	TES-W23F3	EUDAMED	IVD General	Active
Tropicamide Rapid Test	TPM-U11 TPM-U23	EUDAMED	IVD General	Active
Carisopodol (SOMA) Rapid Test	CAR-U11 CAR-U23	EUDAMED	IVD General	Active
Calprotectin Rapid Test	CPT-F23	EUDAMED	IVD General	Active
E2 Fia	E2-W23F3	EUDAMED	IVD General	Active
Follicle Stimulating Hormone FSH Rapid Test Midstream	FSH-U35	EUDAMED	IVD devices for self-testing	Active
25-OH Vitamin D Chemiluminescence Immunoassay Test Kit	G020A08	EUDAMED	IVD General	Active
RSV Antigen Nasal test Kit	RSV-W35	EUDAMED	IVD General	Active
Fastep	MI-S33001H5	EUDAMEDFDA 510(k)	IVD devices for self-testing	Active
Rotavirus and Adenovirus Combo Rapid Test	A4A230	EUDAMED	Class B	Active

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