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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

What Acon Biotech (Hangzhou) Co., Ltd. makes

Acon Biotech (Hangzhou) Co., Ltd. manufactures nucleic acid extraction/isolation kits for in vitro diagnostic use, single-use blood lancets, antigen rapid tests for SARS-CoV-2 self-testing, urine analyzers, hemoglobin and cholesterol test strips and meters, hematology reagents, and real-time PCR systems.

The company's devices are classified as Class A, Class IIa, IVD Annex II List B, IVD General, and IVD devices for self-testing, and are listed in the EUDAMED registry. The manufacturer is based in China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Acon Biotech (Hangzhou) Co., Ltd. manufacture?

Where is Acon Biotech (Hangzhou) Co., Ltd. based?

Acon Biotech (Hangzhou) Co., Ltd. is based in China, as indicated by the country code CN in the device data and confirmed in the summary section which states the manufacturer is based in China.

In which regulatory registry are Acon Biotech (Hangzhou) Co., Ltd.'s devices listed?

Acon Biotech (Hangzhou) Co., Ltd.'s devices are listed in the EUDAMED registry, as explicitly stated in the LISTED IN field and reiterated in the summary section of the provided device data.

How are Acon Biotech (Hangzhou) Co., Ltd.'s devices classified?

Acon Biotech (Hangzhou) Co., Ltd.'s devices are classified as Class A, Class IIa, IVD Annex II List B, IVD General, and IVD devices for self-testing, according to the DEVICE CLASSES field and confirmed in the summary section of the provided device data.

AI-generated from registry data and not verified by a human reviewer.

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 2 of 3

Device	Model / Reference	Registries	Class	Status
On Call Sure Sync Blood Glucose Monitoring System	G115-10W	EUDAMED	IVD Annex II List B	Active
Quik-Check Expert U500 Urine Analyzer	U213-117-201	EUDAMED	Class A	Active
Mission Ultra Hemoglobin Testing System	C111-6011	EUDAMED	IVD devices for self-testing	Active
Mission 3D Hematology Reagent (Mi-Po Cleaner)	C121-9031-201	EUDAMED	Class A	Active
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)	L031-118P5	EUDAMED	IVD devices for self-testing	Active
Promotor Viral Transport Media	P121-1441-201	EUDAMED	Class A	Active
QUIK-CHECK HDL High Density Lipoprotein Test Devices	C131-2037	EUDAMED	IVD devices for self-testing	Active
Flowflex SARS-CoV-2 Antigen Rapid Test Lollipop(Saliva))	L031-125U5	EUDAMED	IVD General	Active
Mission Ultra Cholesterol Control Solution	C121-5011	EUDAMED	IVD devices for self-testing	Active
On Call Plus Blood Glucose Meter	G113-211	EUDAMED	IVD Annex II List B	Active
QUIK-CHECK CHOL Total Cholesterol Test Devices	C131-2017	EUDAMED	IVD devices for self-testing	Active
Promotor Nucleic Acid (DNA) Extraction Kit	P121-1201-201	EUDAMED	Class A	Active
Promotor Nucleic Acid (DNA) Extraction Kit	P121-1101-201	EUDAMED	Class A	Active
Mission U120 Smart Urine Analyzer	U117-111-201	EUDAMED	Class A	Active
Mission U120 Smart Urine Analyzer	U117-101-201	EUDAMED	Class A	Active
Promotor Nucleic Acid Extraction Kit	P121-1301-201	EUDAMED	Class A	Active
Promotor NES-32 Nucleic Acid Extraction System	P111-1011-201	EUDAMED	Class A	Active
On Call Lancets	G124-10A	EUDAMED	Class IIa	Active
QUIK-CHECK Ultra Cholesterol Meter	C111-5037	EUDAMED	IVD devices for self-testing	Active
Quik-Check 3D Hematology Reagent (Mi-Po Cleaner)	C121-9037-201	EUDAMED	Class A	Active
Mission Safety Lancets I	C121-3061	EUDAMED	Class IIa	Active
QUIK-CHECK Cholesterol Control Solution	C121-2017	EUDAMED	IVD devices for self-testing	Active
On Call Plus Blood Glucose Monitoring System	G113-111	EUDAMED	IVD Annex II List B	Active
Mission Ultra Total Cholesterol Test Strips	C131-5011	EUDAMED	IVD devices for self-testing	Active
On Call Plus Glucose Control Solution	G123-311	EUDAMED	IVD Annex II List B	Active
On Call EZ II Blood Glucose Meter	G113-254	EUDAMED	IVD Annex II List B	Active
Promotor Viral Transport Media	P121-1371-201	EUDAMED	Class A	Active
On Call Sure Sync Blood Glucose Meter	G115-11W	EUDAMED	IVD Annex II List B	Active
Promotor Viral Transport Media	P121-1421-201	EUDAMED	Class A	Active
Quik-Check Expert U120 Smart Urine Analyzer	U118-101-201	EUDAMED	Class A	Active
MIssion TRIG Triglycerides Test Devices	C131-2021	EUDAMED	IVD devices for self-testing	Active
QUIK-CHECK Ultra Hemoglobin Control Solution	C121-6017	EUDAMED	IVD devices for self-testing	Active
Promotor Nucleic Acid (RNA) Extraction Kit	P121-1121-201	EUDAMED	Class A	Active
Mission U500 Urine Analyzer	U211-101-201	EUDAMED	Class A	Active
On Call Extra Blood Gucose Test Strips	G135-11H	EUDAMED	IVD Annex II List B	Active
Promotor Viral Transport Media	P121-1341-202	EUDAMED	Class A	Active
Quik-Check Expert U500 Urine Analyzer	U213-107-201	EUDAMED	Class A	Active
On Call Blood Uric Acid Test Strips	GU134-10D	EUDAMED	IVD devices for self-testing	Active
On Call Plus Blood Glucose Test Strips	G133-112	EUDAMED	IVD Annex II List B	Active
Promotor Nucleic Acid (DNA) Extraction Kit	P121-1201-202	EUDAMED	Class A	Active
Mission Cholesterol Meter	C111-2041	EUDAMED	IVD devices for self-testing	Active
On Call Sure Blood Glucose Meter	G115-11U	EUDAMED	IVD Annex II List B	Active
Promotor Viral Transport Media	P121-1401-201	EUDAMED	Class A	Active
Promotor Viral Nucleic Acid Isolation Kit	P121-1051-201	EUDAMED	Class A	Active
ROMO CHECK PLUS Lancets	GS-9008-10L	EUDAMED	Class IIa	Active
Promotor Viral DNA/RNA Isolation Kit	P121-1291-201	EUDAMED	Class A	Active
On Call Sure Blood Glucose Test Strips	G135-11U	EUDAMED	IVD Annex II List B	Active
On Call Smart Pro Blood Glucose/Ketone/Uric Acid Analyzer	GN112-111-201	EUDAMED	IVD General	Active
On Call MultiPro Analyzer	G116-112-201	EUDAMED	Class A	Active
Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing)	L031-118W5	EUDAMED	IVD devices for self-testing	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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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.

There is 1 recall record for Acon Biotech (Hangzhou) Co., Ltd., initiated on 2022-01-09, with statuses recorded as open and classified. The reason given for the recall is that 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.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.