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iTero Lumina PC cfg

by Align Technology Ltd. 2 variants

Ref 223100

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 Number081606302LMN22SYSEL Basic UDI-DI 00816063023203UDI-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  • Withdrawn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
Model / Reference
223100
Primary DI / UDI-DI
00816063023203
Basic UDI-DI
081606302LMN22SYSEL
EMDN Code
Z110601 Laser imaging scanner
Device Class
Class I
Medical Purpose
iTero Lumina PC cfg intraoral scanning unit: The iTero Lumina PC cfg intraoral scanning unit is intended to capture 3D and 2D color images of the patient’s oral cavity. The intraoral scanner is intended to record the topographical images of teeth, oral tissue and bite relationship and to obtain optical impressions for use in CAD/CAM of dental devices. iTero Lumina software: The data processing, displayed and stored by the iTero Lumina Software may be used by dental healthcare professionals for assessing intraoral topographical images of hard and soft tissue and visual assessments.

Manufacturer details

EUDAMED SRN
IL-PR-000047276

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Properties

Other properties (1)

  • Sterile: No