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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 3 of 6

Device	Model / Reference	Registries	Class	Status
Progestin FIA	Prog-F23F3	EUDAMED	IVD General	Active
PropepsinⅠ FIA	PG I-W23F3	EUDAMED	IVD General	Active
COVID-19&Influenza A/B&RSV&ADV Antigen combo Test	Format (cassette): A49330;Format (pen): A49560	EUDAMED	Class B	Active
Influenza A/B Rapid Test Device	A46071	EUDAMED	Class B	Active
Clonazepam Rapid Test	CLO-U11 CLO-U23	EUDAMED	IVD General	Active
Amphetamine FIA	AMP-H23F3	EUDAMED	IVD General	Active
Methaqualone Rapid Test	MQL-U11 MQL-U23	EUDAMED	IVD General	Active
Meperidine Rapid Test	MPRD-U11, MPRD-U23	EUDAMED	IVD General	Active
Fentanyl FIA	FYL-U23F3	EUDAMED	IVD General	Active
Tilidin Rapid Test	TLD-U11 TLD-U23	EUDAMED	IVD General	Active
Vaginal pH Test Device	PH-S23H	EUDAMED	IVD devices for self-testing	Active
Fsh Fia	FSH-W23F3	EUDAMED	IVD General	Active
Caffeine Rapid Test	CAF-U11 CAF-U23	EUDAMED	IVD General	Active
Anti-mullerian hormone FIA	AMH-W23F3	EUDAMED	IVD General	Active
Rotavirus＆Adenovirus Antigen Fecal Combo Test Kit	MI-F42001	EUDAMED	IVD General	Active
COVID-19 Antigen FIA	COV-S23F3	EUDAMED	IVD General	Active
Serum amyloid A FIA	SAA-W23F3	EUDAMED	IVD General	Active
Hydromorphone Rapid Test	HMO-U11 HMO-U23	EUDAMED	IVD General	Active
Lp-PLA2 FIA	LP-W23F3	EUDAMED	IVD General	Active
Methylenedioxypyrovalerone Rapid Test	MDPV-U11 MDPV-U23	EUDAMED	IVD General	Active
Strep A Rapid Test	A4631011, A46310120, A46310140, A4631021, A46310220, A46310240; A46300120, A46300140, A46300220, A46300240	EUDAMED	Class B	Active
NT-ProBNP FIA	BNP -W23F3	EUDAMED	IVD General	Active
Tramadol Rapid Test	TML-U11 TML-U23	EUDAMED	IVD General	Active
Crp Fia	CRP-W23F3	EUDAMED	IVD General	Active
Free Thyroxine (fT4) FIA	FT4-W23F3	EUDAMED	IVD General	Active
C. difficile Toxin B FIA	CDF B-F23F3	EUDAMED	IVD General	Active
Pregabalin Rapid Test	PGB-U11 PGB-U23	EUDAMED	IVD General	Active
Methamphetamine Rapid Test	MET-U11 MET-U23	EUDAMED	IVD General	Active
Carbohydrate Antigen 15-3 FIA	CA153-W23F3	EUDAMED	IVD General	Active
Fentanyl Rapid Test	FYL-U11 FYL-U23	EUDAMED	IVD General	Active
Zolpidem	ZOL-U11, ZOL-U23	EUDAMED	IVD General	Active
Human Chorionic Gonadotropin Rapid Test	HCG-U11 HCG-U23 HCG-U35	EUDAMED	IVD General	Active
FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device	MI-S45001	EUDAMED	IVD General	Active
Astrovirus FIA	ASV-F23F3	EUDAMED	IVD General	Active
Urinalysis 11T Rapid Test	URS-U11T	EUDAMED	IVD General	Active
Lh Fia	LH-W23F3	EUDAMED	IVD General	Active
Mescaline Rapid Test	MES-U11 MES-U23	EUDAMED	IVD General	Active
Ketamine Rapid Test	KET-U11 KET-U23	EUDAMED	IVD General	Active
Myoglobin FIA	MYO-W23G3	EUDAMED	IVD General	Active
Microalbumin and Creatinine Urinalysis Reagent Strips	ALB/CRE-U11	EUDAMED	IVD General	Active
High-sensitive Cardiac Troponin I Chemiluminescence Immunoassay Test Kit	G104A08	EUDAMED	IVD General	Active
Faecal Occult Blood Rapid Test	FOB-F23	EUDAMED	IVD General	Active
Propoxyphene Rapid Test	PPX-U11, PPX-U23	EUDAMED	IVD General	Active
Covid-19&Flu A/B Fia	MI-S22MF3	EUDAMED	IVD General	Active
C. difficile Toxin A FIA	CDF A-F23F3	EUDAMED	IVD General	Active
Syphilis Rapid Test	SYP-P11 SYP-P23 SYP-W11 SYP-W23	EUDAMED	IVD General	Active
Mycoplasma Pneumoniae Antigen Rapid Test Device	A46710	EUDAMED	Class B	Active
PropepsinⅡ FIA	PG II-W23F3	EUDAMED	IVD General	Active
Β-Hcg Fia	β-HCG-W23F3	EUDAMED	IVD General	Active
Marijuana Rapid Test	THC-U11 THC-U23	EUDAMED	IVD General	Active

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