Pro-Flex® Pivot
by Össur Iceland ehf. Iceland EUDAMED
Ref PFP0526RBRModel BU00046
EMDN Y062403
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5690967BU00046NH | Date27 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- BU00046, PFP0526RBR
- Primary DI / UDI-DI
- 05690977444362
- Basic UDI-DI
- 5690967BU00046NH
- EMDN Code
- Y062403 Foot partial prostheses (including toe prostheses)
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- IS-MF-000000173
Other devices from Össur Iceland ehf.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED ad5842c9-4972-40ad-a508-94bf5d6ce63d