← Back to catalogue
Dental X-ray Tomographic System
EUDAMEDClass IIb (EU MDR)
Ref HiRes3D-MaxModel HiRes3D
Identity
- Device Name
- Dental X-ray Tomographic System EUDAMED
- Model / Reference
- HiRes3D EUDAMEDHiRes3D-Max EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972782481022 EUDAMED
- Basic UDI-DI
- 697278248H3DT7 EUDAMED
- Direct Marketing DI
- 06972782481022 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 | 697278248H3DT7 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LargeV Instrument Corp., Ltd.
- EUDAMED SRN
- CN-MF-000028675
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 102f2330-d7ab-4548-97b5-3d2bf69d398a 61 fields · synced Jun 19, 2026