Quality

Our company conducts production and sales activities under China's strict medical device supervision system.

We are certified under the ISO13485/9001 Quality Management System. 

Mostly of the products are sold in the Chinese market, we have a complete China Food and Drug Administration license (CFDA), and in order to expand overseas markets, we also have CE certificates .

Based on the new MDR directive, we have also submitted the application for the new CE certificates, all certifications are in progress, and all certifications are expected to be completed in 2023.

 

 

Standard: ISO9001 Number: Issue Date: 2020-09-01 Expiry Date: 2023-08-31 Scope/Range: Trauma Implant, Spinal fixation implant, etc Issued By: Beijing Huaguang Certification Of Medical Devices Co.,Ltd

Standard: CE Number: HD60***** 001 Issue Date: 2020-03-05 Expiry Date: 2024-05-26 Scope/Range: Spinal Fixation , Metal plate and screws , Interlock nail Issued By: TUV Rheinland

Standard: CE Number: M.2021.106.14560 Issue Date: 2021-05-10 Expiry Date: 2024-05-27 Scope/Range: Sterile Knee Joint Prostheses-Class III Issued By: UDEM

Standard: ISO13485 Number: Issue Date: 2020-09-01 Expiry Date: 2024-08-31 Scope/Range: Trauma Implant, Spinal fixation implant, etc Issued By: Beijing Huaguang Certification Of Medical Devices Co.,Ltd