Lower Limb Brace
by Changzhou Pubang Medical Equipment Co., Ltd. EUDAMED
Active
Ref GB-W04Model Knee Fixation Strap:GF-D01、GF-D02、GF-D03、GF-D03Ⅰ、GF-D03 Ⅱ、GF-D03 Ⅲ、GF-D04、GF-D04 Ⅰ、GF-D04 Ⅱ、GF-D04 Ⅲ、GF-D05、GF-D05 Ⅰ、GF-D05 Ⅱ、GF-D05 Ⅲ、GF-D06、GF-D07、GF-D08、GF-D09、GF-D10、etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697067603LowerLimbBrace4R | Date8 Aug 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Lower Limb Brace
- Model / Reference
- Knee Fixation Strap:GF-D01、GF-D02、GF-D03、GF-D03Ⅰ、GF-D03 Ⅱ、GF-D03 Ⅲ、GF-D04、GF-D04 Ⅰ、GF-D04 Ⅱ、GF-D04 Ⅲ、GF-D05、GF-D05 Ⅰ、GF-D05 Ⅱ、GF-D05 Ⅲ、GF-D06、GF-D07、GF-D08、GF-D09、GF-D10、etc, GB-W04
- Primary DI / UDI-DI
- 06970676030363
- Basic UDI-DI
- 697067603LowerLimbBrace4R
- EMDN Code
- Y060615 Elbow orthoses
- Device Class
- Class I
- 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