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Orthophos E 6707470

by SIRONA Dental Systems GmbH

Ref 6707470

Orthophos E 6707470 is a device classified as Class IIb in the EU and Class II in the US made by SIRONA Dental Systems GmbH, registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-+E27667074700) and listed in FDA GUDID since 8 Sep 2021 (UDI-DI +E27667074700), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+E27667074700 Basic UDI-DI +E27667074700UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+E27667074700 UDI-DI Date8 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-+E27667074700 registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI +E27667074700 listed 8 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +E27667074700
  2. Registered EUDAMED B-+E27667074700

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Orthophos E individ. EUDAMED
Orthophos E GUDID
Generic name
Stationary panoramic dental x-ray system, digital
Model / reference
6707470
Primary DI / UDI-DI
+E27667074700 EUDAMED
E27667074700 GUDID
Basic UDI-DI
B-+E27667074700
FDA product code
EHD
EMDN code
Z11031101 Multifunctional systems for direct digital radiology
GMDN term
Stationary panoramic dental x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.1800
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E27667074700
GUDID
E27667074700
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E27667074700; FDA GUDID lists E27667074700), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Stationary panoramic dental x-ray system, digital

Similar devices in this category

Other devices filed under MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY.

Other devices from SIRONA Dental Systems GmbH

See all devices from SIRONA Dental Systems GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)