Identity
- Device Name
- Dental X-ray Tomographic System EUDAMED
- Model / Reference
- Smart3D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972782481107 EUDAMED
- Basic UDI-DI
- 697278248S3DUW EUDAMED
- Direct Marketing DI
- 06972782481107 EUDAMED
- EMDN Code
- Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental X-ray Tomographic System by LargeV Instrument Corp., Ltd. — Class IIb — 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 | 697278248S3DUW | Class IIb | Active |
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Manufacturer
- Manufacturer
- LargeV Instrument Corp., Ltd.
- EUDAMED SRN
- CN-MF-000028675
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 580ce89d-a3d6-46ab-9950-6a143c98bf78 61 fields · synced Jun 17, 2026