Original von Rosen LARGE
Ref VR10105Model hip abduction brace
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 | Number73500132302JS 07350013231056 | Date21 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- Withdrawn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
- Original von Rosen splint
- Model / Reference
- hip abduction brace, VR10105
- Primary DI / UDI-DI
- 07350013231056
- Basic UDI-DI
- 73500132302JS
- EMDN Code
- Y061215 Hip orthoses (including abduction orthoses)
- Device Class
- Class I
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- SE-MF-000001604
Other devices from Isakssons Gummifabrik AB
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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