EUDAMED device

iTero Lumina - PC cfg intraoral scanning unit

EUDAMED device 00816063023050 · Align Technology Ltd.

Key facts

Primary DI 00816063023050
Trade name iTero Lumina - PC cfg intraoral scanning unit
Device name iTero Lumina PC cfg Intraoral Scanning Unit
Reference or catalog number 223102
Manufacturer Align Technology Ltd.
Manufacturer SRN IL-MF-000000745
Risk class Class I
EMDN code Z110601
EMDN description LASER IMAGING SCANNER
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Nov 5, 2025

At a glance

  • No Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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