Q010699
by Flexafil SACI Argentina EUDAMED
Ref Q010699
EMDN Q010699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number30522838442INYECTABLESF2 | Date1 Dec 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Polymeric Resins for dental prostheses, pain release, splints and dental prostheses retainers
- Model / Reference
- Q010699
- Primary DI / UDI-DI
- 07798399351904
- Basic UDI-DI
- 30522838442INYECTABLESF2
- Direct Marketing DI
- 07798399351904
- 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 & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED b69eb469-9461-48df-9c56-966b4db3a2fb