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NewTom VG-One

by CEFLA s.c. Italy EUDAMED

Ref 70EM0000Model Panoramic, cephalometric and tomographic X-ray equipment

EMDN Z1103030102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803383793IMXRAYEXB001SY Basic UDI-DIDate13 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Panoramic, cephalometric and tomographic X-ray equipment, 70EM0000
Primary DI / UDI-DI
08033837936787
Basic UDI-DI
803383793IMXRAYEXB001SY
Direct Marketing DI
08033837936787
EMDN Code
Z1103030102 Equipment for extraoral dental radiology, digital
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009228

Other devices from CEFLA s.c.

See all devices from CEFLA s.c. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED c44c8821-94f9-422f-80d4-453eedc051fa 61 fields · synced 24 Oct 2026