Henan Simedice Biotechnologies Co., Ltd.

Henan Simedice Biotechnologies Co., Ltd. specializes in intraocular lenses (IOLs), including preloaded aspheric intraocular lenses and toric intraocular lenses. These devices are designed for cataract surgery to replace the eye’s natural lens and address refractive errors like nearsightedness, farsightedness, or astigmatism.

The company is headquartered in China. Its location influences its adherence to regulatory standards applicable in that region, though its devices may also comply with international requirements like those of the EU for market access.

The intraocular lenses produced by Henan Simedice Biotechnologies Co., Ltd. fall under Class IIb classification in the EU regulatory framework. This classification applies to devices posing a moderate risk, requiring additional scrutiny such as clinical evaluations or post-market surveillance to ensure safety and performance.

Yes, the company’s intraocular lenses are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. Listing in this system helps ensure transparency and traceability for regulatory oversight and market surveillance.