eudamed_udi Primary ID: 00816063023067

iTero Lumina Pro Software (UDI 00816063023067)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The iTero Lumina Pro Software (Model/Catalog Number: 225979) is a medical device manufactured by Align Technology Ltd.. This product is indexed under FDA Product Code / Category Classification V92 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 225979
Product Code / EMDN: V92
Device Name: iTero Lumina Pro Software
Database Sync Date: 2026-08-09 18:23:07

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of iTero Lumina Pro Software?

The registered manufacturer of record for iTero Lumina Pro Software is Align Technology Ltd..

What is the Primary UDI-DI identifier for iTero Lumina Pro Software?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00816063023067.

What classification code is assigned to this device?

This device is registered under product classification code V92.

Similar Classification Devices (V92)

Other Devices by Align Technology Ltd.

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