Freedom Cover
Ref FC 360 REG
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 | Number08600078502MYJAFOBKWK 00792105508122 | Date17 Jun 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- Withdrawn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
- Freedom Cover
- Model / Reference
- FC 360 REG
- Primary DI / UDI-DI
- 00792105508122
- Basic UDI-DI
- 08600078502MYJAFOBKWK
- EMDN Code
- Y062499 Lower extremity prostheses - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000016739
- Authorised representative
- Eurolink Europe Compliance Limited IE-AR-000002852
From the manufacturer
Manufacturer's product page: BK Freedom CoverL5704 · $295
Other devices from MY JAFO Llc
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