Identity
- Trade Name
- DEXIS Titanium Accessory Layer EUDAMED
- Device Name
- Intraoral Positioning System EUDAMED
- Model / Reference
- 1.014.6150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D090101461500 EUDAMED
- Basic UDI-DI
- ++D090ClassIJE EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
DEXIS Titanium Accessory Layer by Dental Imaging Technologies Corporation — 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 | ++D090ClassIJE | Class I | Active |
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Manufacturer
- Manufacturer
- Dental Imaging Technologies Corporation
- EUDAMED SRN
- US-MF-000017139
- Authorised Representative
- PaloDEx Group Oy FI-AR-000004955
Sources (1)
- EUDAMED 6e9e95ca-3b45-4f7a-bcdb-a413084f67de 61 fields · synced Jul 10, 2026