获得MDR-CE证书代表时代天使产品完全满足欧盟对医疗器械安全性、有效性及全生命周期合规性的强 制性法律要求，具有极高的国际认可度与市场公信力。时代天使CEO胡杰章在授证仪式上表示，经过两 年多的国际化发展，时代天使海外业务增长迅速，今年上半年的国际病例数占总案例数比例已超过 50%，业务覆盖60多个国家和地区。此次获得CE认证，是时代天使全球化进程中的重要里程碑，也将 进一步夯实公司在国际隐形矫治市场中的竞争基础。 智通财经APP获悉，时代天使(06699)涨超5%，截至发稿，涨4.57%，报68.7港元，成交额2369.52万港 元。 消息面上，据时代天使官网消息，近日，时代天使在上海举办MDR-CE证书授证仪式。TÜV南德意志集 团(以下简称"TÜV南德")在授权仪式上为时代天使正式颁发CE实体证书。此次获得国际权威欧盟公告机 构(Notified Body)的认可，标志着时代天使隐形矫治相关产品在安全性、有效性及合规性方面全面符合 欧盟医疗器械法规要求，也意味着时代天使在高标准海外市场准入上迈出重要一步。 ...

获得MDR-CE证书代表时代天使产品完全满足欧盟对医疗器械安全性、有效性及全生命周期合规性的强 制性法律要求，具有极高的国际认可度与市场公信力。时代天使CEO胡杰章在授证仪式上表示，经过两 年多的国际化发展，时代天使海外业务增长迅速，今年上半年的国际病例数占总案例数比例已超过 50%，业务覆盖60多个国家和地区。此次获得CE认证，是时代天使全球化进程中的重要里程碑，也将 进一步夯实公司在国际隐形矫治市场中的竞争基础。 消息面上，据时代天使官网消息，近日，时代天使在上海举办MDR-CE证书授证仪式。T V南德意志集 团(以下简称"T V南德")在授权仪式上为时代天使正式颁发CE实体证书。此次获得国际权威欧盟公告机 构(Notified Body)的认可，标志着时代天使隐形矫治相关产品在安全性、有效性及合规性方面全面符合 欧盟医疗器械法规要求，也意味着时代天使在高标准海外市场准入上迈出重要一步。 时代天使(06699)涨超5%，截至发稿，涨4.57%，报68.7港元，成交额2369.52万港元。 ...

T V南德是欧盟官方授权的公告机构，在医疗器械认证领域具有全球公认的专业权威性。本次时代天使 所获的MDR-CE证书，是依据欧盟《医疗器械法规》(Medical Device Regulation，MDR)颁发的准入凭 证，MDR也是全球最严格的医疗器械监管体系之一，获得这项证书需经过公告机构对产品技术、临床 评价、质量管理体系及上市后监督等多个维度的系统性、多轮次严格审核，流程严谨、复杂，标准极 高。因此，获得MDR-CE证书代表时代天使产品完全满足欧盟对医疗器械安全性、有效性及全生命周期 合规性的强制性法律要求，具有极高的国际认可度与市场公信力。 时代天使CEO胡杰章表示，作为全球隐形矫治品牌，时代天使获得CE认证源于公司在产品研发、质量 体系与合规能力上的长期积累，也得益于T V南德在专业层面的严格要求。自启动全球化战略以来，时 代天使选择优先进入欧美等发达市场，这意味着企业必须在法规理解、数据安全、产品质量、认证流程 等方面全面对标西方最高标准，并以当地医生的使用习惯和认知逻辑来提供产品与服务。 本报讯(记者李春莲)近日，时代天使生物科技有限公司(以下简称"时代天使")在上海举办MDR-CE证书 授证 ...

（编辑 郭之宸） TÜV南德是欧盟官方授权的公告机构，在医疗器械认证领域具有全球公认的专业权威性。本次时代天 使所获的MDR-CE证书，是依据欧盟《医疗器械法规》（Medical Device Regulation，MDR）颁发的准 入凭证，MDR也是全球最严格的医疗器械监管体系之一，获得这项证书需经过公告机构对产品技术、 临床评价、质量管理体系及上市后监督等多个维度的系统性、多轮次严格审核，流程严谨、复杂，标准 极高。因此，获得MDR-CE证书代表时代天使产品完全满足欧盟对医疗器械安全性、有效性及全生命周 期合规性的强制性法律要求，具有极高的国际认可度与市场公信力。 时代天使CEO胡杰章表示，作为全球隐形矫治品牌，时代天使获得CE认证源于公司在产品研发、质量 体系与合规能力上的长期积累，也得益于TÜV南德在专业层面的严格要求。自启动全球化战略以来， 时代天使选择优先进入欧美等发达市场，这意味着企业必须在法规理解、数据安全、产品质量、认证流 程等方面全面对标西方最高标准，并以当地医生的使用习惯和认知逻辑来提供产品与服务。 本报讯 （记者李春莲）近日，时代天使生物科技有限公司（以下简称"时代天使"）在上海举办M ...

本报讯 （记者李春莲）近日，时代天使生物科技有限公司（以下简称"时代天使"）在上海举办MDR- CE证书授证仪式。TV南德意志集团（以下简称"TV南德"）代表团专程莅临现场，为时代天使正式颁发 CE实体证书。此次获得国际权威欧盟公告机构（Notified Body）的认可，标志着时代天使隐形矫治相 关产品在安全性、有效性及合规性方面全面符合欧盟医疗器械法规要求，也意味着时代天使在高标准海 外市场准入上迈出重要一步。 TV南德是欧盟官方授权的公告机构，在医疗器械认证领域具有全球公认的专业权威性。本次时代天使 所获的MDR-CE证书，是依据欧盟《医疗器械法规》（Medical Device Regulation，MDR）颁发的准入 凭证，MDR也是全球最严格的医疗器械监管体系之一，获得这项证书需经过公告机构对产品技术、临 床评价、质量管理体系及上市后监督等多个维度的系统性、多轮次严格审核，流程严谨、复杂，标准极 高。因此，获得MDR-CE证书代表时代天使产品完全满足欧盟对医疗器械安全性、有效性及全生命周期 合规性的强制性法律要求，具有极高的国际认可度与市场公信力。 （文章来源：证券日报） 时代天使CEO胡杰章表示 ...

Core Viewpoint - Angelalign (06699) reported strong mid-year performance with significant revenue and profit growth, driven by international market expansion and increased case numbers [1] Financial Performance - Revenue for the first half of the year reached $161.4 million, a year-on-year increase of 33.1% [1] - Adjusted net profit was $19.5 million, reflecting an 84.8% increase compared to the previous year [1] - Profit attributable to shareholders was $14.64 million, showing a substantial year-on-year growth of 362.65% [1] Operational Highlights - Total cases of invisible orthodontics increased by 47.7% year-on-year, reaching approximately 225,800 cases [1] - International market cases surged by 103.5% year-on-year, totaling about 117,200 cases, surpassing the domestic market's 108,600 cases [1] - The management raised the annual case volume guidance to between 490,000 and 500,000, indicating a year-on-year growth of 36% to 39% [1] Profitability Metrics - Gross margin remained stable at 62.4%, consistent with the same period last year [1] - Domestic business maintained good profitability despite strategic price adjustments [1] - Overseas gross margin improved from 58.3% in the previous year to 61.2% [1]

Group 1 - The core viewpoint of the article highlights that Times Angel (06699) has shown strong performance in the first half of the year, with a revenue growth of 33% driven primarily by rapid expansion in overseas markets [1] - The report anticipates that the strong growth in cases for Times Angel will continue in the second half of the year, maintaining a "Buy" rating and raising the target price from HKD 69.55 to HKD 86.47 [1] - The total number of invisible orthodontic cases achieved by the group in the first half reached 225,800, representing a year-on-year increase of 48%, surpassing the bank's annual expectation of 517,000 and exceeding the historical average of 410,000 [1] Group 2 - The net profit margin attributable to the company significantly improved to 9.1%, an increase of 6.5 percentage points year-on-year, benefiting from effective cost control measures, delayed hiring, and postponed commissioning of overseas production facilities [1]

Core Viewpoint - Angelalign (06699) reported strong financial performance for the first half of 2025, with significant increases in revenue, profit, and case numbers for invisible orthodontics [1] Financial Performance - Revenue reached $161.4 million, a year-on-year increase of 33.1% [1] - Gross profit was approximately $100 million, reflecting a 32.9% year-on-year growth [1] - Adjusted net profit amounted to $19.5 million, up 84.8% compared to the previous year [1] - Profit attributable to the company's owners was $14.64 million, showing a remarkable year-on-year increase of 362.65% [1] - Earnings per share stood at $0.09, with a special interim dividend of HKD 0.46 per share [1] Operational Highlights - The total number of invisible orthodontic cases grew by 47.7% year-on-year, reaching approximately 225,800 cases [1] - International market cases accounted for about 117,200, while cases in the Chinese market were approximately 108,600 [1]

Core Viewpoint - Angelalign (06699) reported strong financial results for the first half of 2025, showcasing significant growth in revenue, profit, and case numbers in the invisible orthodontics market [1] Financial Performance - Revenue reached $161.4 million, a year-on-year increase of 33.1% [1] - Gross profit was approximately $100 million, reflecting a 32.9% year-on-year growth [1] - Adjusted net profit amounted to $19.5 million, up 84.8% compared to the previous year [1] - Profit attributable to shareholders was $14.64 million, marking a substantial increase of 362.65% year-on-year [1] - Earnings per share stood at $0.09, with a special interim dividend of HKD 0.46 per share [1] Market Performance - The total number of invisible orthodontic cases grew by 47.7% year-on-year, reaching approximately 225,800 cases [1] - International market cases accounted for about 117,200, while cases in the Chinese market were approximately 108,600 [1]

Core Viewpoint - Angelalign (06699) experienced a significant stock price increase of over 7%, reaching HKD 73.2 with a trading volume of HKD 183 million following the announcement of its mid-term results for 2025 [1] Financial Performance - The company reported a revenue of USD 161.4 million for the mid-term of 2025, representing a year-on-year increase of 33.1% [1] - Gross profit was approximately USD 100 million, showing a year-on-year growth of 32.9% [1] - Adjusted net profit reached USD 19.5 million, marking an impressive year-on-year increase of 84.8% [1] - Profit attributable to shareholders was USD 14.64 million, reflecting a substantial year-on-year growth of 362.65% [1] - Earnings per share stood at USD 0.09, with a special interim dividend of HKD 0.46 per share [1] Market Growth - The total number of invisible orthodontic cases grew by 47.7% year-on-year, reaching approximately 225,800 cases [1] - International market cases accounted for about 117,200, while cases in the Chinese market were approximately 108,600 [1]