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OPTI-TRAY Einmalabdrucklöffel
EUDAMEDClass I (EU MDR)
Ref 31201Ref 31213Ref 31203Ref 31202
Identity
- Device Name
- OPTI-TRAY Einmalabdrucklöffel EUDAMED
- Model / Reference
- 31201 EUDAMED31213 EUDAMED31203 EUDAMED31202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EPRF312011/ EUDAMED+EPRF312131/ EUDAMED+EPRF312031/ EUDAMED+EPRF312021/ 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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Also classified as Dental impression tray, single-use.
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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 (4)
- EUDAMED 0ce8a1f3-73ab-4ccc-94e1-e967184997ec 61 fields · synced Aug 3, 2026
- EUDAMED da3a2459-b65d-4d04-8d61-7758729412e1 61 fields · synced May 17, 2026
- EUDAMED 0ea179bb-77dd-438a-bcac-6abfa3ad14d9 61 fields · synced May 17, 2026
- EUDAMED f2518489-9f6b-4cfc-954e-f33430cc09d6 61 fields · synced May 17, 2026