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Sign in to claim this brandAcon 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?
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, as stated in the provided device data summary.
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.com/company/acon-biotech
- facebook.com/acon.biotech.77
- [email protected]
- Phone
- +86 571 87775615
- PRRC Contact
- Andy Xu
- EUDAMED SRN
- CN-MF-000006977
- FDA FEI Number
- 3002829675
- DUNS Number
- —
Catalogue (121)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 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 |
| Quik-Check U500 Urine Analyzer | U211-117-201 | EUDAMED | Class A | Active |
| On Call Extra Blood Glucose Meter | G115-12H | EUDAMED | IVD Annex II List B | Active |
| On Call GU Dual Blood Glucose and Uric Acid Meter | GU114-11D | EUDAMED | IVD devices for self-testing | Active |
| On Call Uric Acid Control Solution | GU124-12D | EUDAMED | IVD devices for self-testing | Active |
| On Call Sure Blood Glucose Meter | G115-13U | EUDAMED | IVD Annex II List B | Active |
| On Call Plus Blood Glucose Test Strips | G133-111 | EUDAMED | IVD Annex II List B | Active |
Related Companies
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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. |