Identity
- Trade Name
- ProphyStar G4 - weiss, mittel EUDAMED
- Device Name
- Polierer / Arkansas EUDAMED
- Model / Reference
- 16412 EUDAMEDPSM4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E312PSM41 EUDAMED
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E312PSM4101 EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Liechtenstein EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
ProphyStar G4 - weiss, mittel by Edenta Etablissement — 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 | ++E31216412DU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (1)
- EUDAMED c0b48d0f-ed05-4a9a-89e4-b49c4816a006 61 fields · synced Jun 19, 2026