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iTero PPC DOA, Lumina

by Align Technology Ltd.

Ref 226084Model iTero Plus Series Platform, Accessories for iTero Scanners

Active European Union

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0081606302PlusMCU5U Basic UDI-DI 00816063023968UDI-DIDate14 Dec 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
iTero Plus Series Platform, Accessories for iTero Scanners
Model / Reference
iTero Plus Series Platform, Accessories for iTero Scanners, 226084
Primary DI / UDI-DI
00816063023968
Basic UDI-DI
0081606302PlusMCU5U
EMDN Code
Q010280 Prosthetic dentistry devices - accessories
Device Class
Class I
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