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NewTom VG-One

EUDAMED

Class IIb (EU MDR)

Ref 70EL0000Model Panoramic, cephalometric and tomographic X-ray equipmentRef 70EF0000Ref 70EM0000Ref 70ED0000

by CEFLA s.c.

Identity

Trade Name
NewTom VG-One EUDAMED
Model / Reference
Panoramic, cephalometric and tomographic X-ray equipment EUDAMED
70EL0000 EUDAMED
70EF0000 EUDAMED
70EM0000 EUDAMED
70ED0000 EUDAMED

Identifiers

Primary DI / UDI-DI
08033837936770 EUDAMED
08033837936121 EUDAMED
08033837936787 EUDAMED
08033837936091 EUDAMED
Basic UDI-DI
803383793IMXRAYEXB001SY EUDAMED
Direct Marketing DI
08033837936770 EUDAMED
08033837936121 EUDAMED
08033837936787 EUDAMED
08033837936091 EUDAMED
EMDN Code
Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Italy 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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

NewTom VG-One by CEFLA s.c. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
CEFLA s.c.
EUDAMED SRN
IT-MF-000009228

Sources (4)

  • EUDAMED e6beeaf5-6af0-40c2-8ab8-b08325d245a6 61 fields · synced Jul 20, 2026
  • EUDAMED 329966da-7173-43d7-b05e-629be9ceaa3f 61 fields · synced May 17, 2026
  • EUDAMED c44c8821-94f9-422f-80d4-453eedc051fa 61 fields · synced May 18, 2026
  • EUDAMED 5a5d0ace-095e-49df-8ddd-8b55b36206dd 61 fields · synced May 18, 2026