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Omni Löffeladhäsiv Polyether Liquid
EUDAMEDClass I (EU MDR)
Ref 56834Model 121
by PRISMAN GmbH
Identity
- Trade Name
- Omni Löffeladhäsiv Polyether Liquid EUDAMED
- Device Name
- Adhäsiv Liquid POLYETHER EUDAMED
- Model / Reference
- 121 EUDAMED56834 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064797001066 EUDAMED
- Basic UDI-DI
- ++EPRM121DD EUDAMED
- EMDN Code
- Q01020103 DENTAL IMPRESSION POLYETHERS 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 Löffeladhäsiv Polyether Liquid 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 | ++EPRM121DD | Class I | Active |
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Manufacturer
- Manufacturer
- PRISMAN GmbH
- EUDAMED SRN
- DE-MF-000009900
Sources (1)
- EUDAMED db539676-f3c6-45fd-b3ad-961055e45ba9 61 fields · synced Jun 18, 2026