Upper limb fixator
by Xiamen Benli Medical Technology Co., Ltd.
Ref Wrist-BL-82010Model Wrist-BL-82010/Wrist-BL-82011/Wrist-BL-82012/Wrist-BL-82018/Wrist-BL-6052/Wrist-BL-82003/Wrist-BL-82008/Wrist-BL-82013/Wrist-BL-82015/Knuckles-BL-86222/Knuckles-BL-22005 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 | Number697922669ULF001V4 06979226690019 | 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- Withdrawn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
- Upper limb fixator
- Model / Reference
- Wrist-BL-82010/Wrist-BL-82011/Wrist-BL-82012/Wrist-BL-82018/Wrist-BL-6052/Wrist-BL-82003/Wrist-BL-82008/Wrist-BL-82013/Wrist-BL-82015/Knuckles-BL-86222/Knuckles-BL-22005 etc, Wrist-BL-82010
- Primary DI / UDI-DI
- 06979226690019
- Basic UDI-DI
- 697922669ULF001V4
- EMDN Code
- Y090612 Arm and elbow protections
- 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