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HELIODENT Plus 6483692

by SIRONA Dental Systems GmbH

Ref 6483692

HELIODENT Plus 6483692 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 28 Oct 2026 (Basic UDI-DI B-+E27664836920) and listed in FDA GUDID since 10 Sep 2016 (UDI-DI +E27664836920), 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-+E27664836920 Basic UDI-DI +E27664836920UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+E27664836920 UDI-DI Date10 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-+E27664836920 registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI +E27664836920 listed 10 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +E27664836920
  2. Registered EUDAMED B-+E27664836920

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  • Withdrawn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
HD PLUS complete w/o support arm (wall module, square) EUDAMED
HELIODENT Plus GUDID
Generic name
Stationary intraoral dental x-ray system, digital
Model / reference
6483692
Primary DI / UDI-DI
+E27664836920 EUDAMED
E27664836920 GUDID
Basic UDI-DI
B-+E27664836920
FDA product code
EHD
EMDN code
Z1103040101 Equipment for conventional endoral radiology
GMDN term
Stationary intraoral 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
+E27664836920
GUDID
E27664836920
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E27664836920; FDA GUDID lists E27664836920), 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 intraoral dental x-ray system, digital

Similar devices in this category

Other devices filed under EQUIPMENT FOR CONVENTIONAL ENDORAL 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)