Omega
by PF mobility ApS Denmark EUDAMED
Ref 5100100, 5100140, 5100150
EMDN Y121806
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5745000343DIO4C | Date11 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- OmegaOmega P25
- Device Name
- Adaptive cycle
- Model / Reference
- 5100100, 5100140, 5100150
- Primary DI / UDI-DI
- 05745000343041, 05745000343393, 05745000343386
- Basic UDI-DI
- 5745000343DIO4C, 5745000343DP20T6
- Direct Marketing DI
- 057450003430410574500034339305745000343386
- EMDN Code
- Y121806 Pedal tricycles
- Device Class
- Class I
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- DK-MF-000018768
Other devices from PF mobility ApS
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 (3)
- EUDAMED 7656767d-c094-4df1-989d-85d280b53b10
- EUDAMED 05745000343393|5745000343DP20T6
- EUDAMED 05745000343386|5745000343DP20T6