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OMNI DENT Omnisuc Cleaner
EUDAMEDClass I (EU MDR)
Ref 200865Model 440, 444, 441, 445, 443
by PRISMAN GmbH
Identity
- Trade Name
- OMNI DENT Omnisuc Cleaner EUDAMED
- Device Name
- Prophylaxepaste CLEAN RDA 40, CLEAN RDA 120, CLEAN RDA 170, CLEAN RDA 250, VARIOSHAPE EUDAMED
- Model / Reference
- 440, 444, 441, 445, 443 EUDAMED200865 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064797030325 EUDAMED
- Basic UDI-DI
- ++EPRM440DY EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
OMNI DENT Omnisuc Cleaner by PRISMAN GmbH — Class I — 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 | ++EPRM440DY | Class I | Active |
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Manufacturer
- Manufacturer
- PRISMAN GmbH
- EUDAMED SRN
- DE-MF-000009900
Sources (1)
- EUDAMED ebb14c79-b49c-480d-b431-220fa525fa29 61 fields · synced Jul 19, 2026