Lower extremity fixator
by Xiamen Benli Medical Technology Co., Ltd. 22 variants
Ref Knee-BL-42008Model Knee-BL-42001/Knee-BL-42003/Knee-BL-42005/Knee-BL-42006/Knee-BL-42007/Knee-BL-42008/Knee-BL-42009/Knee-BL-42010/Knee-BL-42011/Knee-BL-42012/Knee-BL-42014/Knee-BL-42015/Knee-BL-42017/Knee-BL-42251/Knee-BL-42253/Knee-BL-42002 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 | Number697922669LEF001P2 06979226690378 | Date27 Oct 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- Withdrawn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
- Lower extremity fixator
- Model / Reference
- Knee-BL-42001/Knee-BL-42003/Knee-BL-42005/Knee-BL-42006/Knee-BL-42007/Knee-BL-42008/Knee-BL-42009/Knee-BL-42010/Knee-BL-42011/Knee-BL-42012/Knee-BL-42014/Knee-BL-42015/Knee-BL-42017/Knee-BL-42251/Knee-BL-42253/Knee-BL-42002 etc, Knee-BL-42008
- Primary DI / UDI-DI
- 06979226690378
- Basic UDI-DI
- 697922669LEF001P2
- EMDN Code
- Y090618 Leg and knee protections (including socks for amputated legs)
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000050097
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xiamen Benli Medical Technology Co., Ltd.
See all devices from Xiamen Benli Medical 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