Hong Kong Stock Movement | ANGELALIGN (06699) Rises Over 5%, Obtains TÜV SÜD EU MDR-CE Certificate for Clear Aligner Products, Advances High-Standard Overseas Market Access

Stock News01-08

ANGELALIGN (06699) rose over 5%. As of the time of writing, the stock was up 4.57%, trading at HK$68.7, with a turnover of HK$23.6952 million. According to an announcement on the company's official website, ANGELALIGN recently held a certificate awarding ceremony in Shanghai for the MDR-CE certificate. TÜV SÜD (hereinafter referred to as "TÜV SÜD") formally presented the physical CE certificate to ANGELALIGN during the authorization ceremony. This recognition from an internationally authoritative EU Notified Body signifies that ANGELALIGN's clear aligner-related products fully comply with the safety, efficacy, and regulatory requirements of the EU Medical Device Regulation, marking a significant step forward for the company in gaining access to high-standard overseas markets. Obtaining the MDR-CE certificate demonstrates that ANGELALIGN's products completely meet the EU's mandatory legal requirements for the safety, efficacy, and full-lifecycle compliance of medical devices, granting them a high degree of international recognition and market credibility. At the certificate ceremony, ANGELALIGN CEO Hu Jiezhang stated that after more than two years of international development, the company's overseas business has grown rapidly, with the proportion of international cases accounting for over 50% of the total case volume in the first half of this year, and its business now covers more than 60 countries and regions. This acquisition of the CE certification is a significant milestone in ANGELALIGN's globalization process and will further solidify the company's competitive foundation in the international clear aligner market.

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