ENFORCE Active Foot
by ENforce Medical Technologies Sp. z o.o. 4 variants
Ref EAF54Model EAF13,EAF14,EAF15,EAF33,EAF34,EAF35,EAF53,EAF54,EAF55,EAF63,EAF64,EAF65
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 | Number59054969507ACTIVEFOOT75 05906952972189 | Date14 Feb 2025 | 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- Withdrawn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
- Model / Reference
- EAF13, EAF14, EAF15, EAF33, EAF34, EAF35, EAF53, EAF54, EAF55, EAF63, EAF64, EAF65
- Primary DI / UDI-DI
- 05906952972189
- Basic UDI-DI
- 59054969507ACTIVEFOOT75
- Direct Marketing DI
- 05906952972189
- EMDN Code
- Y062403 Foot partial prostheses (including toe prostheses)
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000043797
Other devices from ENforce Medical Technologies Sp. z o.o.
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