Hicren (Zhejiang) Medtech Co., Ltd.

Hicren (Zhejiang) Medtech specializes in single-use orthopedic and spinal instruments. Their portfolio includes disposable burs for bone preparation, balloon catheters used for spinal dilation, and a spinal shaver system blade designed for tissue removal. They also produce bone cement delivery cannulas for vertebral augmentation, percutaneous access needles for minimally invasive procedures, and bone cement mixing sets for surgical preparation. These devices are tailored for orthopedic and spinal surgeries.

Hicren (Zhejiang) Medtech Co., Ltd. is based in China. The company’s location influences its regulatory compliance requirements, particularly for devices marketed in regions like the EU, where additional documentation and registration may be necessary.

Yes, Hicren’s devices are listed in the EUDAMED registry, which is the European database for medical devices. Listing in EUDAMED is required for devices placed on the EU market, ensuring transparency and traceability for regulatory oversight. This registry helps healthcare professionals and authorities verify the manufacturer and device details.

Under EU regulations, Hicren’s devices are classified as Class I or Class IIa. The classification depends on factors like the device’s intended use, risk level, and interaction with the body. For example, disposable burs (often Class I) are considered low-risk, while balloon catheters or bone cement delivery systems (potentially Class IIa) involve slightly higher risks due to their procedural use and potential impact on patient safety. Classification determines the regulatory requirements for conformity assessment and market authorization.