eudamed_udi
Primary ID: 00816063021599
iTero Lumina Scanning Unit (UDI 00816063021599)
Manufactured by Align Technology Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for iTero Lumina Scanning Unit - Primary ID 00816063021599
Device Regulatory Overview
The iTero Lumina Scanning Unit (Model/Catalog Number: 214500) 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
- 214500
- Product Code / EMDN
- Z110601
- Device Name
- iTero Lumina System
- Database Sync Date
- 2026-08-09 16:51:32
Full Regulatory Attributes
đŸ”’ Token Gated
{
"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 Lumina Scanning Unit?
The registered manufacturer of record for iTero Lumina Scanning Unit is Align Technology Ltd..
What is the Primary UDI-DI identifier for iTero Lumina Scanning Unit?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00816063021599.
What classification code is assigned to this device?
This device is registered under product classification code Z110601.
Similar Classification Devices (Z110601)
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