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iTero PPC DOA, Lumina Pro Mobile

by Align Technology Ltd. EUDAMED

Active European Union

Ref 226094Model iTero Plus Series Platform, Accessories for iTero Scanners

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0081606302PlusMCU5U Basic UDI-DIDate14 Dec 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
iTero Plus Series Platform, Accessories for iTero Scanners
Model / Reference
iTero Plus Series Platform, Accessories for iTero Scanners, 226094
Primary DI / UDI-DI
00816063024064
Basic UDI-DI
0081606302PlusMCU5U
EMDN Code
Q010280 Prosthetic dentistry devices - accessories
Device Class
Class I
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