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Ningbo Chiwell Biotechnology Co., Ltd

China Last updated 25 Oct 2026 Part of Ningbo Chiwell Biotechnology Co., Ltd

Devices
29
Registries
EUDAMEDGUDIDFDA
FDA recalls
0

Catalogue29

Authorised representatives

What Ningbo Chiwell Biotechnology Co., Ltd makes

Ningbo Chiwell Biotechnoology Co., Ltd. manufactures diagnostic in vitro devices under the CHIWELL brand, including tests for infectious diseases, allergens, and general health markers. These products are designed for point-of-care and laboratory use, covering serological assays, rapid tests, and immunoassays.

The company’s portfolio is classified under EU Medical Device Regulation (MDR) as Class A devices, with records submitted to 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

How many devices does Ningbo Chiwell Biotechnology Co., Ltd have in the registry?

The registry currently lists 29 devices for Ningbo Chiwell Biotechnology Co., Ltd. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ningbo Chiwell Biotechnology Co., Ltd's devices?

Among its 29 most recently registered devices, Ningbo Chiwell Biotechnology Co., Ltd has devices listed in EUDAMED (25 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Ningbo Chiwell Biotechnology Co., Ltd's devices fall under?

Among its 29 most recently registered devices, the classes recorded for Ningbo Chiwell Biotechnology Co., Ltd's devices are Class I and IVDR Class A. Each device page shows its own class and authorisation.

What are the newest devices from Ningbo Chiwell Biotechnology Co., Ltd in the registry?

The most recently registered devices listed for Ningbo Chiwell Biotechnology Co., Ltd include CHIWELL, Automatic Slide Stainer, Chiwell Biotechnology E8 and Chiwell Biotechnology E6.

Generated automatically from registry data and not verified by a human reviewer.

Information

Address
3F, Building 18, Zone A, No. 68 Yuhai East Road, Qianwan New District, , Ningbo, Zhejiang Province (Digital Economy Industrial Park), China
Website
126.com
PRRC contact
BuTong Ding
EUDAMED SRN
CN-MF-000034310
FDA FEI number
3043088157
DUNS number
413940020