Ba 30601 Uruni
by Bi̇oakti̇f Tibbi̇ Ürünler Ve Tekni̇k Teksti̇l San. Ti̇c. Ltd. Şti̇.
Ref BA 30601 URUNIModel SPLINTS
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 | Number86824950ATELXT 08682495017651 | Date26 May 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- Withdrawn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
- Splints
- Model / Reference
- SPLINTS, BA 30601 URUNI
- Primary DI / UDI-DI
- 08682495017651
- Basic UDI-DI
- 86824950ATELXT
- Direct Marketing DI
- 08682495017651
- EMDN Code
- Y060613 Wrist-hand-fingers orthoses
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000045383
Other devices from Bi̇oakti̇f Tibbi̇ Ürünler Ve Tekni̇k Teksti̇l San. Ti̇c. Ltd. Şti̇.
See all devices from Bi̇oakti̇f Tibbi̇ Ürünler Ve Tekni̇k Teksti̇l San. 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