Certifications 资质认证

HEIDSTAR digital pathology scanners hold NMPA medical device registration and ISO 13485:2016 certification. 海德星科技的数字病理扫描仪已取得 NMPA 医疗器械注册证及 ISO 13485:2016 认证。

NMPA Medical Device Registration Certificate — Pathology Slide Scanner (HDS-MSCAN-200A), Reg. No. 闽械注准20222220152, valid until 2027-12-20. 病理切片扫描仪医疗器械注册证（型号 HDS-MSCAN-200A，注册证编号 闽械注准20222220152，有效期至 2027-12-20）。

ISO 13485:2016 Medical Device Quality Management System Certificate (No. 117 26 MD 0037 R2 00, valid until 2029-04-14) — design & production of digital pathology slide scanner components.

海德星科技 ISO 13485:2016 医疗器械质量管理体系认证证书（证书编号 117 26 MD 0037 R2 00，有效期至 2029-04-14）。

NMPA medical device change-registration document dated 2025-06-06 listing HEIDSTAR pathology slide scanner models HDS-MSCAN-120A, HDS-MSCAN-200A and HDS-MSCAN-240A under registration No. 闽械注准20222220152

NMPA medical device change-registration document dated 2025-06-06 listing HEIDSTAR pathology slide scanner models HDS-MSCAN-120A, HDS-MSCAN-200A and HDS-MSCAN-240A under registration No. 闽械注准20222220152