Ningbo Chiwell Biotechnology Co., Ltd

Ningbo Chiwell Biotechnoology Co., Ltd. specializes in diagnostic in vitro devices under the CHIWELL brand. These include tests for infectious diseases, allergens, and general health markers, such as serological assays, rapid tests, and immunoassays. The devices are intended for both point-of-care and laboratory use, helping detect biomarkers or pathogens for diagnostic purposes.

The company is headquartered in Ningbo, China. This location reflects its operational base for manufacturing, research, and regulatory compliance activities related to its diagnostic in vitro devices.

Devices manufactured by Ningbo Chiwell Biotechnoology Co., Ltd. are listed in the EUDAMED registry, which is the European Union’s database for medical devices. This registry tracks information about devices placed on the EU market, including their classification and regulatory status.

All devices from Ningbo Chiwell Biotechnoology Co., Ltd. fall under Class A classification according to the EU Medical Device Regulation (MDR). This classification applies to low-risk in vitro diagnostic devices, such as certain rapid tests and basic health marker assays, which pose minimal risk to users.