Identity
- Trade Name
- DentiAnn Impression Tray EUDAMED
- Device Name
- Impression Tray EUDAMED
- Model / Reference
- ITUM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800156402138 EUDAMED
- Basic UDI-DI
- 88001564SEIL02J5 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
DentiAnn Impression Tray by Seil Global — 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 | 88001564SEIL02J5 | Class I | Active |
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Manufacturer
- Manufacturer
- Seil Global
- EUDAMED SRN
- KR-MF-000013925
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 7b744f15-19ea-45ee-88ab-7fecb0fb2e48 61 fields · synced Jun 17, 2026