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Primevision 3D 6823426

by SIRONA Dental Systems GmbH EUDAMEDGUDID

Active European Union

Ref 6823426

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E276EOImaging0256 Basic UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+E27668234260 UDI-DIDate13 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Primevision 3D
Generic Name
Stationary panoramic/tomographic dental x-ray system, digital
Model / Ref / Catalog
6823426
Primary DI / UDI-DI
+E27668234260 EUDAMED
E27668234260 GUDID
Basic UDI-DI
++E276EOImaging0256
FDA Product Code
OAS
EMDN Code
Z11031101 Multifunctional systems for direct digital radiology
GMDN Term
Stationary panoramic/tomographic dental x-ray system, digital
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1750
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E27668234260
GUDID
E27668234260
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from SIRONA Dental Systems GmbH

See all devices from SIRONA Dental Systems GmbH →

Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No