Softmode
by Zandar Ayakkabi Ltd Sti EUDAMED
Active
Ref 862BLK36
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8681009SFTMD026L | Date20 Oct 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Orthopedic Boots Made of Leather with Removable Insole
- Model / Reference
- 862BLK36
- Primary DI / UDI-DI
- 08681009002480
- Basic UDI-DI
- 8681009SFTMD026L
- EMDN Code
- Y063303 Ready-made orthotic shoes
- Device Class
- Class I
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000039136
Other devices from Zandar Ayakkabi Ltd Sti
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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