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iTero Element 5D Plus (rental)

by Align Technology Ltd. EUDAMED

Active European Union

Ref 225991Model iTero Element 5D Family

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081606302DISBH Basic UDI-DIDate17 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3903048CE01 Active

    Quality management system EU MDR

    Notified body
    0344
    Issued
    18 Jun 2024
    Expires
    1 Jun 2029

Specification

EUDAMED

Device Name
iTero Element 5D Family
Model / Reference
iTero Element 5D Family, 225991
Primary DI / UDI-DI
00816063023630
Basic UDI-DI
081606302DISBH
EMDN Code
Z110601 Laser imaging scanner
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
IL-MF-000000745
Authorised representative
Align Technology B.V. NL-AR-000000061

Other devices from Align Technology Ltd.

See all devices from Align Technology Ltd. →

Properties

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