eudamed_udi Primary ID: 00816063020837

iTero Plus Computing unit (UDI 00816063020837)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The iTero Plus Computing unit (Model/Catalog Number: 211385) is a medical device manufactured by Align Technology Ltd.. This product is indexed under FDA Product Code / Category Classification Q010280 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 211385
Product Code / EMDN: Q010280
Device Name: iTero Plus Series Platform, Accessories for iTero Scanners
Database Sync Date: 2026-08-09 16:28:50

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 Plus Computing unit?

The registered manufacturer of record for iTero Plus Computing unit is Align Technology Ltd..

What is the Primary UDI-DI identifier for iTero Plus Computing unit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00816063020837.

What classification code is assigned to this device?

This device is registered under product classification code Q010280.

Similar Classification Devices (Q010280)

Other Devices by Align Technology Ltd.

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