Identity
- Trade Name
- Dentapreg® PFM Refill EUDAMED
- Device Name
- Dentapreg® PFM EUDAMED
- Model / Reference
- D-004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595652700061 EUDAMED
- Basic UDI-DI
- 85956527PFM92 EUDAMED
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dentapreg® PFM Refill by ADM, a.s. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 85956527PFM92 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ADM, a.s.
- EUDAMED SRN
- CZ-MF-000032589
Sources (1)
- EUDAMED 8d4582cd-d836-434c-af1b-2b4c4ffd7a04 61 fields · synced Jun 19, 2026