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NewTom VGi evo
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref P70700011Model Computed tomograph for dental radiology
by CEFLA s.c.
Identity
- Trade Name
- NewTom VGi evo EUDAMEDNewTom FDA UDI
- Generic Name
- Cone beam computed tomography system, head/neck FDA UDI
- Device Name
- X-ray imaging device comprising an X-ray acquisition system and the control box, for producing two and three dimensional views for computation and display. FDA UDI
- Model / Reference
- Computed tomograph for dental radiology EUDAMEDP70700011 EUDAMEDNewTom VGi evo FDA UDI
- Description
- X-ray imaging device comprising an X-ray acquisition system and the control box, for producing two and three dimensional views for computation and display. FDA UDI
Identifiers
- Catalog Number
- P70700011 FDA UDI
- Primary DI / UDI-DI
- 08033837931348 EUDAMEDFDA UDI
- Basic UDI-DI
- 803383793IMXRAYEXB002T2 EUDAMED
- Direct Marketing DI
- 08033837931348 EUDAMED
- FDA Product Code
- OAS FDA UDI
- EMDN Code
- Z11030699 COMPUTED TOMOGRAPHS (CT) - OTHER EUDAMED
- GMDN Term
- Cone beam computed tomography system, head/neck FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
NewTom VGi evo by CEFLA s.c. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803383793IMXRAYEXB002T2 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (2)
- EUDAMED b5b50153-77ca-4a36-9a0f-6105aee666de 61 fields · synced Jul 17, 2026
- FDA UDI 1cae24ba-0094-4431-a65a-32a06ed370ee 36 fields · synced May 30, 2026