GAUSH MEDITECH (02407): Gaush Innovation Receives CE Certificate for Corneal Confocal Microscope.

GAUSH MEDITECH (02407) announced that its subsidiary, Gaoshichuangxin Technology Co., Ltd. (Gaoshichuangxin), recently officially obtained the corneal confocal microscopes CE registration certificate issued by DEKRA (Certificate No.: 6208923CE01). The acquisition of this important qualification signifies that the company's corneal confocal microscopes fully comply with the strict standards of the EU MDR regulations, and its technological strength has received international recognition. This not only establishes a solid foundation for the company to expand global sales and international development but also solidifies its strategic position in the international high-end ophthalmic medical market based on high-standard products and hardcore technological strength. DEKRA, founded in 1925, is a globally leading independent non-listed professional inspection and certification organization covering a wide range of industries. The EU CE certification is a mandatory qualification for medical devices to enter the European market, demonstrating compliance with EU MDR regulations. It not only focuses on product safety and performance but also emphasizes risk management and clinical evaluation throughout the product lifecycle. Through CE certification, it means that the company's products meet EU unified standards in various stages such as design and development, production, clinical validation, and post-market surveillance, making it one of the highest recognized entry thresholds in the global medical device market.