Guangzhou Rainhome Pharm & Tech Co., Ltd

Guangzhou Rainhome Pharm & Tech Co., Ltd manufactures the welsuc device, which appears to be a single product line. Based on the available information, this device is designed for clinical or procedural use, though its exact application is not specified beyond its name. The company specialises in this one product, which is classified under both Class IIa and Class IIb in the EU regulatory framework.

The company is headquartered in China, specifically in Guangzhou. This location is relevant for understanding its operational base and regulatory context, particularly for devices marketed or used in international markets.

Yes, the welsuc device is registered in the eudamed database, which is the European Union’s centralised registry for medical devices. This listing indicates compliance with EU regulatory requirements for transparency and traceability, though it does not imply approval or clearance of the device itself.

The welsuc device is classified under both Class IIa and Class IIb in the EU regulatory framework. This classification determines the level of scrutiny and regulatory controls required for its market placement, with Class IIa representing moderate risk and Class IIb indicating a higher risk level requiring additional safety measures and documentation.