Wrist/Thumb Support
Ref 776-TAN-M-1, 752-BK-S-1, 752-BL-S-1, 763-BL-L-1, 576-BK-L-1, 752-TAN-XL-1, 776-BL-S-1, 763-BL-S-1, 563CA-BK-F-1, 763-TAN-XL-1, 752-BK-M-1, 763-TAN-S-1, 776-TAN-S-1, 776-BK-XL-1, 763-BK-S-1, 776-BK-M-1, 776-BK-L-1, 563KM-BK-F-1, 752-BK-L-1, 576-BK-M-1, 776-TAN-XL-1, 776-BL-L-1
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 | Number471988489CL103GL | Date4 Sep 2023 | 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- Withdrawn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 Extremity Orthoses
- Model / Reference
- 776-TAN-M-1, 752-BK-S-1, 752-BL-S-1, 763-BL-L-1, 576-BK-L-1, 752-TAN-XL-1, 776-BL-S-1, 763-BL-S-1, 563CA-BK-F-1, 763-TAN-XL-1, 752-BK-M-1, 763-TAN-S-1, 776-TAN-S-1, 776-BK-XL-1, 763-BK-S-1, 776-BK-M-1, 776-BK-L-1, 563KM-BK-F-1, 752-BK-L-1, 576-BK-M-1, 776-TAN-XL-1, 776-BL-L-1
- Primary DI / UDI-DI
- 04719890060617, 04719884898813, 04719884898820, 04719884899452, 04719884891814, 04719884898929, 04719890060570, 04719884899391, 04719890061553, 04719884899490, 04719884898844, 04719884899407, 04719890060587, 04719890060655, 04719884899384, 04719890060594, 04719890060624, 04719890071620, 04719884898875, 04719884891807, 04719890060679, 04719890060631
- Basic UDI-DI
- 471988489CL103GL
- EMDN Code
- Y060699 Orthoses, upper extremity - other
- Device Class
- Class I
- EU market of registration
- Malta
Manufacturer details
- EUDAMED SRN
- TW-MF-000005197
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Welsheng Corp.
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