Identity
- Device Name
- OPTI-TRAY Einmalabdrucklöffel EUDAMED
- Model / Reference
- 31222 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EPRF312221/ EUDAMED
- Basic UDI-DI
- ++EPRF102OptiTray54 EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE 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
Category: Dental impression tray, single-use
OPTI-TRAY Einmalabdrucklöffel by PROFIMED GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++EPRF102OptiTray54 | Class I | Active |
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Manufacturer
- Manufacturer
- PROFIMED GmbH
- EUDAMED SRN
- DE-MF-000006873
Sources (1)
- EUDAMED 15f7e3d1-dd68-40d6-b575-b1c7c6d44ff5 61 fields · synced Jun 19, 2026