Soles Neoprene Malleolus Ankle Brace Breathable Neoprene, Extreme Comfort - One Size Fits All - Fits Both Feet - Soft, Flexible, Comfortable - Reduces Pain and Prevents Injuries - Stabilizes Ankle
by Tuna Dis Tic. Ve Paz. Ltd. Sti
Ref SOLES6Model Ankle orthoses
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 | Number869891850BILEKLIKMQ 08698918503670 | Date16 Jul 2024 | 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- Withdrawn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
- Ankle orthoses, SOLES6
- Primary DI / UDI-DI
- 08698918503670
- Basic UDI-DI
- 869891850BILEKLIKMQ
- Direct Marketing DI
- 08698918503670
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- TR-MF-000021856
Other devices from Tuna Dis Tic. Ve Paz. Ltd. Sti
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