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iTero Lumina PC cfg Scanning Unit, RMA Package

by Align Technology Ltd. 2 variants

Ref 223125

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081606302LMNSCNUEV Basic UDI-DI 00816063023265UDI-DIDate5 Nov 2025RegisteredStatusActive

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  • Withdrawn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 Lumina PC cfg Intraoral Scanning Unit
Model / Reference
223125
Primary DI / UDI-DI
00816063023265
Basic UDI-DI
081606302LMNSCNUEV
EMDN Code
Z110601 Laser imaging scanner
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