Policold
by Polident d.o.o. Industrija dentalnih proizvodov 10 variants
Ref 02875, 02879, 03058, 03014
Active
CE MDR
Valid until
29 Jul 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR-0014 | Date24 Jun 2026 | StatusActive |
Certificates
- MDR-0014 Restricted
Quality management system EU MDR
- Certifier
- SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ 1304
- Issued
- 24 Jun 2026
- Expires
- 29 Jul 2029
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Denture base material
- Model / Reference
- 02875, 02879, 03058, 03014
- Primary DI / UDI-DI
- +EPOL028750I, +EPOL028790M, +EPOL030580C, +EPOL0301404
- Basic UDI-DI
- ++EPOLDBMJ2
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class IIa
- EU market of registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- SI-MF-000000740
Other devices from Polident d.o.o. Industrija dentalnih proizvodov
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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