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iTero Lumina Scanning Unit RMA Configuration

by Align Technology Ltd. EUDAMEDGUDID

Active European Union

Ref 213353Model iTero Lumina System

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081606302LMNSYS9L Basic UDI-DIDate18 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00816063021469 UDI-DIDate1 Feb 2024ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
iTero Lumina Scanning Unit RMA Configuration EUDAMED
iTero Lumina RMA Scanning Unit GUDID
Generic Name
Dental milling system, CAD/CAM, chairside
Device Name
iTero Lumina System
Model / Reference
iTero Lumina System, 213353
Primary DI / UDI-DI
00816063021469
Basic UDI-DI
081606302LMNSYS9L
FDA Product Code
NOF
EMDN Code
Z110601 Laser imaging scanner
GMDN Term
Dental milling system, CAD/CAM, chairside
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3661
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

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

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No