Suzhou Leapmed Healthcare Corporation

Suzhou Leapmed Healthcare Corporation manufactures disposable and reusable medical devices primarily used in biopsy procedures. Their portfolio includes disposable biopsy guides, reusable biopsy guides, ultrasound biopsy kits, and ultrasound cover kits. These devices are designed to assist in medical imaging and procedural guidance, particularly for ultrasound-assisted interventions.

The company is based in Suzhou, China. This location reflects its operational headquarters and likely its primary manufacturing or development base for its medical devices.

Suzhou Leapmed Healthcare Corporation’s devices are listed in the EU’s EUDAMED registry and the FDA’s 510(k) database. These registries document regulatory authorisation for devices marketed in the European Union and the United States, respectively.

The company’s devices fall into three regulatory classes: Class I (generally low-risk devices), Class II (moderate-risk devices requiring performance standards), and Class IIa (a subset of Class II with specific risk profiles). Classification determines the regulatory scrutiny and requirements for market authorisation, such as conformity assessments or clinical evaluations.

The FDA’s 510(k) database includes devices that have undergone a 510(k) premarket notification process, where the manufacturer demonstrates that their device is substantially equivalent to a legally marketed predicate device. This pathway is used for devices like biopsy guides and ultrasound kits, where equivalence to an existing authorised product supports regulatory clearance in the U.S. market.