Jiangsu Kehua Medical Instrument Technology Co., Ltd.

Jiangsu Kehua Medical Instrument Technology Co., Ltd. specializes in point-of-care testing (POCT) ampules, pre-filled blood collection tubes, and transfer pipettes. The transfer pipettes include capillary pipettes, glass capillary tubes, fixed-volume pipettes, and capillary blood collectors. These devices are designed for small-volume blood handling, often used in clinical or home settings for diagnostic purposes.

The company is based in China. Its manufacturing and operations are conducted within the country, adhering to local regulatory standards for medical devices.

The company’s devices are listed in the eudamed registry, which is the European database for medical devices. This inclusion indicates compliance with EU requirements for low-risk devices, though it does not imply approval or clearance of the company itself.

All devices manufactured by Jiangsu Kehua Medical Instrument Technology Co., Ltd. fall under Class A classification. This classification applies to low-risk medical devices, such as POCT ampules, pre-filled tubes, and transfer pipettes, which pose minimal risk to patients and users.

The devices are authorised under applicable regulatory frameworks for low-risk medical products, including those in the EU where they are listed in eudamed. Authorisation depends on compliance with local regulations, such as the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), but the company itself is not authorised—only its individual devices are evaluated and cleared for market placement.