eudamed_udi Primary ID: 00816063022954

iTero Lumina Scanning Unit RMA (UDI 00816063022954)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The iTero Lumina Scanning Unit RMA (Model/Catalog Number: 216498) is a medical device manufactured by Align Technology Ltd.. This product is indexed under FDA Product Code / Category Classification Z110601 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 216498
Product Code / EMDN: Z110601
Device Name: iTero Lumina System
Database Sync Date: 2026-08-09 17:06:52

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 Scanning Unit RMA?

The registered manufacturer of record for iTero Lumina Scanning Unit RMA is Align Technology Ltd..

What is the Primary UDI-DI identifier for iTero Lumina Scanning Unit RMA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00816063022954.

What classification code is assigned to this device?

This device is registered under product classification code Z110601.

Similar Classification Devices (Z110601)

Other Devices by Align Technology Ltd.

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