NINGBO KONFOONG BIOINFORMATION TECH CO., LTD.

Ningbo Konfoong Bioinformation Tech Co., Ltd. specializes in in vitro diagnostic (IVD) devices under the KFBIO brand. Their portfolio includes reagents, kits, and automated systems for biochemical analysis, such as glucose or lipid testing, as well as point-of-care testing solutions. These devices are designed for clinical laboratories and healthcare settings to aid in diagnostic decision-making, covering both hospital and outpatient environments.

The company is headquartered in Ningbo, China. While its primary operations are based there, its IVD devices are registered in the EU’s eudamed database, indicating compliance with European regulatory requirements for in vitro diagnostics.

The company’s devices are listed in the eudamed database, which is the official EU registry for in vitro diagnostic (IVD) medical devices. This registration aligns with the In Vitro Diagnostic Regulation (IVDR), ensuring transparency and compliance with EU regulatory standards.

The company’s IVD devices fall under Class A classification according to EU regulations. This classification is assigned based on risk assessment criteria, where Class A devices pose minimal risk to patients and users. The classification helps determine regulatory requirements, such as conformity assessment procedures, though Class A devices generally require less stringent scrutiny than higher-risk classes.