Primodent
by Polident d.o.o. Industrija dentalnih proizvodov Slovenia EUDAMED
Ref PRV.03C3Model Type 1/Type 2
EMDN Q010699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR-0014 | Date24 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR-0014 Restricted
Quality management system EU MDR
- Notified body
- SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ 1304
- Issued
- 24 Jun 2026
- Expires
- 29 Jul 2029
- Reason
- Other
Specification
- Device Name
- Artificial Polymer Teeth
- Model / Reference
- Type 1/Type 2, PRV.03C3
- Primary DI / UDI-DI
- +EPOLPRV03C30B
- Basic UDI-DI
- ++EPOLAPTKB
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class IIa
- Market of Registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- SI-MF-000000740
Other devices from Polident d.o.o. Industrija dentalnih proizvodov
See all devices from Polident d.o.o. Industrija dentalnih proizvodov →
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 0f39504e-1b07-4df7-8c75-47c01be5596f