Spinal Support Brace
by Changzhou Pubang Medical Equipment Co., Ltd. 5 variants
Ref GC-X03ⅠModel Thoracolumbar Spine Fixator:GC-X01、GC-X02、GC-X03Ⅰ、GC-X03 Ⅱ、GC-X04Ⅰ、GC-X04 Ⅱ、GC-X05、GC-X06、GC-X07、GC-X08 Head, neck and chest immobilizers：GC-Q01、GC-Q02、GC-Q03 etc
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697067603SpinalLX 06970676032367 | Date8 Aug 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Spinal Support Brace
- Model / Reference
- Thoracolumbar Spine Fixator:GC-X01、GC-X02、GC-X03Ⅰ、GC-X03 Ⅱ、GC-X04Ⅰ、GC-X04 Ⅱ、GC-X05、GC-X06、GC-X07、GC-X08 Head, neck and chest immobilizers：GC-Q01、GC-Q02、GC-Q03 etc, GC-X03Ⅰ
- Primary DI / UDI-DI
- 06970676032367
- Basic UDI-DI
- 697067603SpinalLX
- EMDN Code
- Y060306 Thoracolumbar orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000048852
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Changzhou Pubang Medical Equipment Co., Ltd.
See all devices from Changzhou Pubang Medical Equipment Co., Ltd. →
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No