Gallant - Fpk-01 - Gallant Panorami̇k Fosfor Plak Kilifi
by Ki̇bar Dental Tibbi̇ Malzemeleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
Ref FPK-01
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 | Number86818127KLF5M 08681812700214 | Date3 Aug 2026 | 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- Withdrawn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
- Gallant Panorami̇k Fosfor Plak, Isirma Çubuğu Ve X-Ray Sensör Kiliflari
- Model / Reference
- FPK-01
- Primary DI / UDI-DI
- 08681812700214
- Basic UDI-DI
- 86818127KLF5M
- EMDN Code
- T030102 Cover sheaths, instruments and equipments
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000055098
Other devices from Ki̇bar Dental Tibbi̇ Malzemeleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
See all devices from Ki̇bar Dental Tibbi̇ Malzemeleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →
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