Identity
- Trade Name
- Assembly-DEXIS Imprevo Tip EUDAMED
- Device Name
- IS 3600 I/O 3D Scanner EUDAMED
- Model / Reference
- 5945150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00693856000333 EUDAMED
- Basic UDI-DI
- 0693856IOSGU EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS 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
Assembly-DEXIS Imprevo Tip 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 | 0693856IOSGU | 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 1a87bb69-b364-4d07-b244-5531410a2e5a 61 fields · synced Oct 6, 2026