GAUSH MEDITECH Subsidiary Secures CE Mark for Corneal Confocal Microscope

Stock News
04/10

GAUSH MEDITECH (02407) has announced that its subsidiary, Gaush Innovation Technology Co., Ltd., recently obtained the CE registration certificate for its corneal confocal microscope, issued by DEKRA (Certificate No.: 6208923CE01). The acquisition of this significant qualification signifies that the company's corneal confocal microscope fully complies with the stringent standards of the European Union's MDR regulations, demonstrating its technical capabilities have gained international authoritative recognition. This achievement not only lays a solid foundation for the company's global sales expansion and international development but also establishes its strategic position to compete in the international high-end ophthalmic medical market with high-standard products and robust technical strength. DEKRA, established in 1925, is a leading global independent non-listed professional inspection, testing, and certification organization covering a wide range of industries. The EU CE marking is a mandatory conformity certification for medical devices entering the European market, indicating that the product meets the requirements of the EU MDR regulations. It focuses not only on product safety and performance but also emphasizes risk management and clinical evaluation throughout the entire product lifecycle. Obtaining CE certification means that the company's product meets the unified standards of the European Union in design and development, production, clinical validation, and post-market surveillance, representing one of the most widely recognized entry thresholds in the global medical device market.

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