EUDAMED device

iTero Lumina Scanning Unit RMA Configuration

EUDAMED device 00816063021476 · Align Technology Ltd.

Key facts

Primary DI 00816063021476
Trade name iTero Lumina Scanning Unit RMA Configuration
Device name iTero Lumina System
Reference or catalog number 213355
Model iTero Lumina System
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 Jun 18, 2024

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:

Browse all EUDAMED devices