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Acon Biotech (Hangzhou) Co., Ltd.

China·CN-MF-000006977

Last updated September 17, 2026

About

Acon Biotech (Hangzhou) Co., Ltd. was established in 1995. It is a biodiagnostic company that has passed the three major certifications of China GMP, European CE, ISO13485 and the US FDA. The company's products are mainly related to POCT, chronic disease management, immunodiagnosis and molecular diagnosis.

From the manufacturer's own website. Source

Information

Country: China
Address: No.210, Zhenzhong Road, Hangzhou, China
Website: www.aconbio.com/index.html
LinkedIn: linkedin.com/company/acon-biotech
Facebook: facebook.com/acon.biotech.77
Email: [email protected]
Phone: +86 571 87775615
PRRC Contact: Andy Xu
EUDAMED SRN: CN-MF-000006977
FDA FEI Number: 3002829675
DUNS Number: —

Catalogue (106)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)	L031-118M5	EUDAMED	IVD devices for self-testing	Active
Quik-Check Expert U120 Smart Urine Analyzer	U118-111-201	EUDAMED	Class A	Active
Mission Ultra Hemoglobin Test Strips	C131-6011	EUDAMED	IVD devices for self-testing	Active
Quik-Check 3D Hematology Reagent (Cyto-Lyser)	C121-9027-201	EUDAMED	Class A	Active
FIAflex FIA Analyzer	F111-10211-201	EUDAMED	Class A	Active
On Call Safety Lancets I	G123-7B1	EUDAMED	Class IIa	Active
QUIK-CHECK Ultra Hemoglobin Test Strips	C131-6017	EUDAMED	IVD devices for self-testing	Active
Mission 3D Hematology Reagent (Cyto-Diluent)	C121-9011-201	EUDAMED	Class A	Active
QUIK-CHECK Cholesterol Meter	C111-2027	EUDAMED	IVD devices for self-testing	Active
QUIK-CHECK Ultra Cholesterol Control Solution	C121-5017	EUDAMED	IVD devices for self-testing	Active
Promotor 960 Real-Time PCR System	P111-2011-201	EUDAMED	Class A	Active
Mission Ultra Cholesterol Monitoring System	C111-5011	EUDAMED	IVD devices for self-testing	Active
On Call Sure Blood Glucose Monitoring System	G115-10U	EUDAMED	IVD Annex II List B	Active
Mission Lancets	C121-3041	EUDAMED	Class IIa	Active
Influenza A/B Rapid Test (Self-Testing)	L031-11935	EUDAMED	IVD devices for self-testing	Active
On Call EZ II Blood Glucose Monitoring System	G113-151	EUDAMED	IVD Annex II List B	Active
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)	L031-118Z5	EUDAMED	IVD devices for self-testing	Active
On Call Extra Blood Glucose Monitoring System	G115-10H	EUDAMED	IVD Annex II List B	Active
On Call Plus Blood Glucose Test Strips	G133-115	EUDAMED	IVD Annex II List B	Active
QUIK-CHECK Ultra Hemoglobin Testing System	C111-6017	EUDAMED	IVD devices for self-testing	Active
Promotor Viral Transport Media	P121-1431-201	EUDAMED	Class A	Active
Mission Ultra Cholesterol Meter	C111-5031	EUDAMED	IVD devices for self-testing	Active
On Call Extra Blood Glucose Meter	G115-13H	EUDAMED	IVD Annex II List B	Active
Quik-Check 3D Hematology Reagent (Cyto-Diluent)	C121-9017-201	EUDAMED	Class A	Active
Mission CHOL Total Cholesterol Test Devices	C131-2011	EUDAMED	IVD devices for self-testing	Active
QUIK-CHECK Cholesterol Test Device 3-in-1 Lipid Panel	C131-2047	EUDAMED	IVD devices for self-testing	Active
Mission Safety Lancets Ⅲ	C121-3101	EUDAMED	Class IIa	Active
On Call Safety Lancets III	G123-7B2	EUDAMED	Class IIa	Active
On Call Blood Uric Acid Test Strips	GU134-11D	EUDAMED	IVD devices for self-testing	Active
QUIK-CHECK Ultra Total Cholesterol Test Strips	C131-5017	EUDAMED	IVD devices for self-testing	Active
Mission Cholesterol Control Solution	C121-2011	EUDAMED	IVD devices for self-testing	Active
On Call Extra Glucose Control Solution	G125-12H	EUDAMED	IVD Annex II List B	Active
QUIK-CHECK TRIG Triglycerides Test Devices	C131-2027	EUDAMED	IVD devices for self-testing	Active
On Call Sure Blood Glucose Test Strips	G135-10U	EUDAMED	IVD Annex II List B	Active
Mission Cholesterol Test Device 3-in-1 Lipid Panel	C131-2041	EUDAMED	IVD devices for self-testing	Active
Mission 3D Hematology Reagent (Cyto-Lyser)	C121-9021-201	EUDAMED	Class A	Active
On Call Sure Glucose Control Solution	G125-12U	EUDAMED	IVD Annex II List B	Active
Promotor Viral Transport Media	P121-1451-201	EUDAMED	Class A	Active
Mission Ultra Hemoglobin Control Solution	C121-6011	EUDAMED	IVD devices for self-testing	Active
On Call Extra Blood Glucose Meter	G115-11H	EUDAMED	IVD Annex II List B	Active
Promotor Whole Blood Genomic DNA Extraction Kit	P121-1111-201	EUDAMED	Class A	Active
FIAflex FIA Analyzer	F111-10111-201	EUDAMED	Class A	Active
On Call Plus Blood Glucose Test Strips	G133-118	EUDAMED	IVD Annex II List B	Active
QUIK-CHECK Cholesterol Monitoring System	C111-2017	EUDAMED	IVD devices for self-testing	Active
Mission Cholesterol Monitoring System	C111-2011	EUDAMED	IVD devices for self-testing	Active
QUIK-CHECK Lancets	C121-3047	EUDAMED	Class IIa	Active
Mission HDL High Density Lipoprotein Test Devices	C131-2031	EUDAMED	IVD devices for self-testing	Active
QUIK-CHECK Ultra Cholesterol Monitoring System	C111-5017	EUDAMED	IVD devices for self-testing	Active
Promotor Sample Collection Kit	P121-1471-201	EUDAMED	Class A	Active
On Call Extra Blood Gucose Test Strips	G135-10H	EUDAMED	IVD Annex II List B	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 9, 2022	Z-0945-2022	—	open, classified	Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results.