Dorsi-Flexion Bandage
by Medi̇mport Sağlik Ürünleri̇ San Ve Ti̇c Ltd Şti̇
Ref OP-302D
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 | Number86825784AYKBIL3C | Date29 Jul 2026 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- Ankle
- Model / Reference
- OP-302D
- Primary DI / UDI-DI
- 08682578403739
- Basic UDI-DI
- 86825784AYKBIL3C
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- TR-MF-000047960
Other devices from Medi̇mport Sağlik Ürünleri̇ San Ve Ti̇c Ltd Şti̇
See all devices from Medi̇mport Sağlik Ürünleri̇ San Ve Ti̇c Ltd Şti̇ →
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