iFIT Prosthesis
by iFIT Prosthetics United States EUDAMED
Ref TF300WRiModel iFITTF300
EMDN Y062415
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0850049686TF300iZE | Date17 Mar 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- iFIT Transfemoral Prosthesis
- Model / Reference
- iFITTF300, TF300WRi
- Primary DI / UDI-DI
- 00850049686266
- Basic UDI-DI
- 0850049686TF300iZE
- Direct Marketing DI
- 00850049686266
- EMDN Code
- Y062415 Transfemoral prostheses (for amputation above knee)
- Device Class
- Class I
- Market of Registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000032928
- Authorised representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Other devices from iFIT Prosthetics
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 61f04ab9-a8bd-4b6c-8b09-153e603eae53