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Yonghe Medical

Certifications & Compliance

Quality system and product certifications that support global market access.

Yonghe Medical maintains a certified quality system and prepares the documentation required for international market access. Certifications and registrations are managed per product family and target market.

Customers can request certificate copies, declarations of conformity, FSC and CO documents together with quotations.

Certifications & Compliance
ISO 13485:2016
Medical devices — quality management systems
ISO 9001:2015
Quality management systems
CE Marking
EU conformity for applicable device families
NMPA Registration
National Medical Products Administration, China
IEC 60601-1
General safety and essential performance
IEC 62304
Medical device software lifecycle