ZAHN-FIT by DIKROPHA
by GAP Research Co. Ltd. EUDAMED
Active
Ref 1028
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5031966GAP102G2 | Date16 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Dr. Denti Tooth-Fil
- Model / Reference
- 1028
- Primary DI / UDI-DI
- 05031966040774
- Basic UDI-DI
- 5031966GAP102G2
- EMDN Code
- Q0101010203 Temporary dental cements
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- UK-MF-000050233
- Authorised representative
- DenVTech Ltd. IE-AR-000048694
Other devices from GAP Research Co. Ltd.
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