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iTero Element 5D Laptop Configuration

by Align Technology Ltd. 2 variants

Ref 212097Model iTero Element 5D Family

Active European Union

CE MDR

Valid until

1 Jun 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081606302DISBH Basic UDI-DI 00816063020936UDI-DIDate17 Dec 2024RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3903048CE01 Active

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    18 Jun 2024
    Expires
    1 Jun 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
iTero Element 5D Family
Model / Reference
iTero Element 5D Family, 212097
Primary DI / UDI-DI
00816063020936
Basic UDI-DI
081606302DISBH
EMDN Code
Z110601 Laser imaging scanner
Device Class
Class IIa
EU 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