Junocare Medical Devices Ltd

Junocare Medical Devices Ltd specializes in laboratory reagents and consumables. Their products include preservative fluids for red and white blood cells, density reagents used for cell separation, staining solutions like EA/Orange-G and hematoxylin, syringing pipettes, adhesive slides, spring-loaded grips, and beveled tips. These items are designed for medical and diagnostic procedures, particularly in hematology and cell processing.

Junocare Medical Devices Ltd is based in China. Their products listed in the EU’s eudamed registry adhere to Good Manufacturing Practice (GMP) standards, ensuring quality and compliance with regulatory requirements for medical devices. The classification of their devices under EU Medical Device Regulations (Class A and Class I) reflects their lower-risk categorization.

Yes, Junocare Medical Devices Ltd’s devices are listed in the eudamed registry, which is the European Union’s central database for medical devices. This registry is used to track devices authorized under EU Medical Device Regulations, ensuring transparency and traceability for regulatory oversight.

Junocare Medical Devices Ltd’s products fall under Class A and Class I classifications in the EU Medical Device Regulations. These classifications are assigned based on risk levels—Class A devices are generally considered low-risk, while Class I devices may have slightly higher risk but still pose minimal threat to patient safety. The classification determines regulatory requirements, including labeling, post-market surveillance, and conformity assessment procedures.