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Dental X-ray Tomographic System
EUDAMEDClass IIb (EU MDR)
Ref HiRes3D-PlusModel HiRes3DRef Smart3D-X SEModel Smart3D-XRef Smart3D-X Pro
Identity
- Trade Name
- Dental X-ray Tomographic System EUDAMED
- Device Name
- Dental X-ray Tomographic System EUDAMED
- Model / Reference
- HiRes3D EUDAMEDHiRes3D-Plus EUDAMEDSmart3D-X EUDAMEDSmart3D-X SE EUDAMEDSmart3D-X Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972782481015 EUDAMED06972782481169 EUDAMED06972782481114 EUDAMED06972782481152 EUDAMED
- Basic UDI-DI
- 697278248H3DT7 EUDAMED697278248S3XW6 EUDAMED
- Direct Marketing DI
- 06972782481169 EUDAMED06972782481114 EUDAMED06972782481152 EUDAMED
- EMDN Code
- Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDBulgaria 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 | 697278248H3DT7 | 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 (4)
- EUDAMED f860e7d4-8666-4e06-bce1-caa8b8b4701c 61 fields · synced Aug 2, 2026
- EUDAMED 4537ccaf-e24a-4bd0-81bd-54a9dd60deee 61 fields · synced May 16, 2026
- EUDAMED 8d472684-3f18-4b54-a8ab-6defc5f51d1c 61 fields · synced May 17, 2026
- EUDAMED c8c31151-711d-44b3-ab1f-b85edee77800 61 fields · synced May 18, 2026