Resin Sabilex PremiumFlex GEN1 IPFGEN1
by Flexafil SACI EUDAMED
Active
Ref 7798399351980
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number30522838442INYECTABLESF2 | Date1 Dec 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Polymeric Resins for dental prostheses, pain release, splints and dental prostheses retainers
- Model / Reference
- 7798399351980
- Primary DI / UDI-DI
- 07798399351980
- Basic UDI-DI
- 30522838442INYECTABLESF2
- Direct Marketing DI
- 07798399351980
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- AR-MF-000031451
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Flexafil SACI
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