Standard Elbow Sleeve M
by BioSkin LLC EUDAMED
Active
Ref 42102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0647552ELBSLEEVEBW | Date3 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Standard Elbow Sleeve
- Model / Reference
- 42102
- Primary DI / UDI-DI
- 00647552502318
- Basic UDI-DI
- 0647552ELBSLEEVEBW
- EMDN Code
- Y060615 Elbow orthoses
- Device Class
- Class I
- 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