Wrist-Thumb Spica Xl-Xxl
Ref 54525R
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 | Number0647552WRISTTHUMBY5 00647552514533 | Date6 Oct 2026 | 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- Withdrawn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
- Wrist-Thumb Spica
- Model / Reference
- 54525R
- Primary DI / UDI-DI
- 00647552514533
- Basic UDI-DI
- 0647552WRISTTHUMBY5
- EMDN Code
- Y060612 Wrist-hand orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000016322
- Authorised representative
- Rollerwerk Medical Engineering & Consulting DE-AR-000015883
Other devices from BioSkin LLC
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