Identity
- Trade Name
- FREEDOM i EUDAMED
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- DSI-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809972790009 EUDAMED
- Basic UDI-DI
- 880997279DSI-100X2 EUDAMED
- Direct Marketing DI
- 08809972790009 EUDAMED
- EMDN Code
- Z11069001 BIOIMAGING PROCESSORS 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
FREEDOM i by DOF Inc — 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 | 880997279DSI-100X2 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DOF Inc
- EUDAMED SRN
- KR-MF-000041580
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 4bb4c260-31cc-4d9e-b149-c12dc2f38eb5 61 fields · synced Aug 1, 2026