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Dentally Vision (previously marketed as Dentrix Ascend Imaging)

by Henry Schein One, LLC

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-(01)00864058000302GR Basic UDI-DI D-(01)00864058000302GRUDI-DIDate17 Nov 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Primary DI / UDI-DI
D-(01)00864058000302GR
Basic UDI-DI
B-(01)00864058000302GR
EMDN Code
Z110603 Picture archiving and communication systems
Device Class
Class I
Special Device Type
-1192
EU market of registration
Malta

Manufacturer details

EUDAMED SRN
US-MF-000038317
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Henry Schein One, LLC

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No