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NewTom GiANO HR
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 70A40000, 70AD0000 Model Panoramic, cephalometric and tomographic X-ray equipmentRef 70A30000, 70AC0000
by CEFLA s.c.
Identity
- Trade Name
- NewTom GiANO HR EUDAMEDNewTom FDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Digital panoramic, cephalometric and tomographic extra-oral X-ray system. FDA UDI
- Model / Reference
- Panoramic, cephalometric and tomographic X-ray equipment EUDAMED70A40000, 70AD0000 EUDAMED70A30000, 70AC0000 EUDAMEDNewTom GiANO HR FDA UDI
- Description
- Digital panoramic, cephalometric and tomographic extra-oral X-ray system. FDA UDI
Identifiers
- Catalog Number
- 70A30000 FDA UDI
- Primary DI / UDI-DI
- 08033837934967 EUDAMED08033837931898 EUDAMEDFDA UDI
- Basic UDI-DI
- 803383793IMXRAYEXB001SY EUDAMED
- Direct Marketing DI
- 08033837934967 EUDAMED08033837931898 EUDAMED
- FDA Product Code
- MUH FDA UDIOAS FDA UDI
- EMDN Code
- Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL EUDAMED
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI892.1750 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 GiANO HR 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 | 803383793IMXRAYEXB001SY | 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 (5)
- EUDAMED efe0d911-a6cd-44e7-81af-227e367cb442 61 fields · synced Aug 3, 2026
- FDA UDI a93a2b9a-0c9a-4557-82bd-e3775331db9b 36 fields · synced May 30, 2026
- EUDAMED de90e312-bf5a-4750-b06d-dfb85dbc626d-1 61 fields · synced Jul 26, 2026
- EUDAMED de90e312-bf5a-4750-b06d-dfb85dbc626d-2 61 fields · synced Jul 26, 2026
- EUDAMED efe0d911-a6cd-44e7-81af-227e367cb442-1 61 fields · synced Aug 3, 2026