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iTero Lumina Scanner Sleeve

by Align Technology (Sichuan) Medical Equipment Co., Ltd. EUDAMED

Active European Union

Ref 223141

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697536203LMNSLVTY Basic UDI-DIDate27 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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 Lumina intraoral scanning
Model / Reference
223141
Primary DI / UDI-DI
06975362030535
Basic UDI-DI
697536203LMNSLVTY
EMDN Code
Z12119085 Various dental stomatology instruments - consumables
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000024868
Authorised representative
Align Technology B.V. NL-AR-000000061

Other devices from Align Technology (Sichuan) Medical Equipment Co., Ltd.

See all devices from Align Technology (Sichuan) Medical Equipment Co., 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