Identity
- Trade Name
- UPPER IMPRESSION TRAY (S) EUDAMED
- Device Name
- UPPER IMPRESSION TRAY (S) EUDAMED
- Model / Reference
- 1097U EUDAMED
Identifiers
- Primary DI / UDI-DI
- D1231097U0 EUDAMED
- Basic UDI-DI
- ++D1231097UF2 EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Silicone dental impression material
Upper Impression Tray (s) by Dental Expert — 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 | ++D1231097UF2 | Class I | Active |
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Manufacturer
- Manufacturer
- Dental Expert
- EUDAMED SRN
- PK-MF-000024595
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED d8d0f4e6-9e89-4f17-b6c2-97e7d98e774c 61 fields · synced Jul 31, 2026