Lower Limb Brace
by Zhejiang Steriger Sports Medicine Technology Co., Ltd. EUDAMED
Active
Ref BDFA-2213Model Ankle support（BDFA-2213、48715、48716、BDFA-12、02579） Knee support（BDFK-1204、48732、48733、BDF-11、02580、BDFK-7878、47878）etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697431877LLB001KT | Date16 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- Ankle support（BDFA-2213、48715、48716、BDFA-12、02579） Knee support（BDFK-1204、48732、48733、BDF-11、02580、BDFK-7878、47878）etc, BDFA-2213
- Primary DI / UDI-DI
- 06974318770501
- Basic UDI-DI
- 697431877LLB001KT
- EMDN Code
- Y061280 Lower limb orthoses - accessories
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000048245
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhejiang Steriger Sports Medicine Technology 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