Identity
- Device Name
- Dental Impression Tray EUDAMED
- Model / Reference
- DITAS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10195291013116 EUDAMED
- Basic UDI-DI
- 0195291DispImpTraysAT EUDAMED
- Unit of Use DI
- 00195291013119 EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Dental Impression Tray by Flexmedics — 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 | 0195291DispImpTraysAT | Class I | Active |
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Manufacturer
- Manufacturer
- Flexmedics
- EUDAMED SRN
- US-MF-000013090
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED b7d2ea82-0f22-48d9-8ff7-83345d53bc95 61 fields · synced May 23, 2026