gudid Primary ID: 225969

iTero Lumina Software (UDI 225969)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The iTero Lumina Software (Model/Catalog Number: 225969) is a medical device manufactured by Align Technology, Inc.. This product is indexed under FDA Product Code / Category Classification NOF within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 225969
Product Code / EMDN: NOF
Device Name: SW, iTero Lumina Products
Database Sync Date: 2026-08-09 09:40:14

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 Software?

The registered manufacturer of record for iTero Lumina Software is Align Technology, Inc..

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

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 225969.

What classification code is assigned to this device?

This device is registered under product classification code NOF.

Similar Classification Devices (NOF)

Other Devices by Align Technology, Inc.

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