EUDAMED device

iTero Lumina Pro Upgrade

EUDAMED device 00816063022459 · Align Technology Ltd.

Key facts

Primary DI 00816063022459
Trade name iTero Lumina Pro Upgrade
Device name iTero Lumina™ Pro / iTero Lumina™ Pro Mobile
Reference or catalog number 221949
Manufacturer Align Technology Ltd.
Manufacturer SRN IL-PR-000047276
Risk class Class IIa
EMDN code Q010207
EMDN description DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY
Legislation mdr
Implantable No
Sterile No
Single use No
Status date May 15, 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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