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NewTom GO
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 70BE0000, 70B2E000Model Panoramic, cephalometric and tomographic X-ray equipmentRef 70BT0000, 70B6T000Ref 70BF0000, 70B2F000
by CEFLA s.c.
Identity
- Trade Name
- NewTom GO 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. Cephalometric arm is optional. FDA UDI
- Model / Reference
- Panoramic, cephalometric and tomographic X-ray equipment EUDAMED70BE0000, 70B2E000 EUDAMED70BT0000, 70B6T000 EUDAMED70BF0000, 70B2F000 EUDAMEDNewTom GO (3D CEPH) FDA UDI
- Description
- Digital panoramic, cephalometric and tomographic extra-oral X-ray system. Cephalometric arm is optional. FDA UDI
Identifiers
- Catalog Number
- 70BE0000 FDA UDI
- Primary DI / UDI-DI
- 08033837932901 EUDAMEDFDA UDI08033837935551 EUDAMED08033837935582 EUDAMED
- Basic UDI-DI
- 803383793IMXRAYEXB001SY EUDAMED
- Direct Marketing DI
- 08033837932901 EUDAMED08033837935551 EUDAMED08033837935582 EUDAMED
- 510(k) Number
- K200688 FDA UDI
- 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 GO 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 (7)
- EUDAMED fbec344d-2423-4fa3-a470-a25b0242bc2f 61 fields · synced Aug 4, 2026
- EUDAMED 9e3bb50e-4e0e-42d7-ab72-d55333911f80 61 fields · synced May 17, 2026
- FDA UDI e493407b-6358-4974-80c1-386e3a03a4e3 37 fields · synced May 30, 2026
- EUDAMED 9e3bb50e-4e0e-42d7-ab72-d55333911f80-1 61 fields · synced Jul 11, 2026
- EUDAMED fbec344d-2423-4fa3-a470-a25b0242bc2f-1 61 fields · synced Jul 22, 2026
- EUDAMED 5128a432-a482-440d-bee8-2abc9b72ebdc-1 61 fields · synced Aug 4, 2026
- EUDAMED 5128a432-a482-440d-bee8-2abc9b72ebdc-2 61 fields · synced Aug 4, 2026