Contact Person : Luffy Liu
Phone Number : +86-15062512110
WhatsApp : +8615062512110
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: | 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 |
| 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 |
Enter Your Message
| Jiangsu Gather Biotech Co.,Ltd |
| B2508,Junma International , Shazhou West Road , Yangshe Town , Zhangjiagang , Jiangsu |
| 86-150-62512110 |
| luffyliu@jsgather.cn |
