BraceID-Velpeau Shoulder Immobiliser
by Orthobroker
Ref 11-0072-1Model 11-0061-1
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 | Number5404020402shoulderelbowCA 05404020400089 | Date26 Aug 2022 | 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- Withdrawn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
- BraceID- OrthoSling Single Unit
- Model / Reference
- 11-0061-1, 11-0072-1
- Primary DI / UDI-DI
- 05404020400089
- Basic UDI-DI
- 5404020402shoulderelbowCA
- EMDN Code
- Y060621 Shoulder orthoses
- Device Class
- Class I
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000000331
Other devices from Orthobroker
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