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Why Can We Always Ensure Excellent Quality

Quality Control

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.

Jiangsu Gather Biotech Co.,Ltd

Certification

Jiangsu Gather Biotech Co.,Ltd Certifications
Standard: ISO9001
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
Jiangsu Gather Biotech Co.,Ltd Certifications
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
Jiangsu Gather Biotech Co.,Ltd Certifications
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
Jiangsu Gather Biotech Co.,Ltd Certifications
Standard: ISO13485
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
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