Enforce Dynamic Foot
by ENforce Medical Technologies Sp. z o.o.
Ref EDF13Model EDF13,EDF14,EDF15,EDF33,EDF34,EDF35,EDF53,EDF54,EDF55,EDF63,EDF64,EDF65
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 | Number59054969507DYNAMICFOOTGL 05905496950769 | Date20 Jan 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- Withdrawn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
- Device Name
- Enforce Dynamic Foot
- Model / Reference
- EDF13, EDF14, EDF15, EDF33, EDF34, EDF35, EDF53, EDF54, EDF55, EDF63, EDF64, EDF65
- Primary DI / UDI-DI
- 05905496950769
- Basic UDI-DI
- 59054969507DYNAMICFOOTGL
- 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