eudamed_udi
Primary ID: 00816063021766
iTero Plus Computing unit (UDI 00816063021766)
Manufactured by Align Technology Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for iTero Plus Computing unit - Primary ID 00816063021766
Device Regulatory Overview
The iTero Plus Computing unit (Model/Catalog Number: 212272) 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
- 212272
- Product Code / EMDN
- Q010280
- Device Name
- iTero Plus Series Platform, Accessories for iTero Scanners
- Database Sync Date
- 2026-08-09 16:50:14
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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Get API Token Access ($49/mo)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 00816063021766.
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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