eudamed_udi
Primary ID: 00816063022121
iTero Lumina Pro Mobile (UDI 00816063022121)
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 Pro Mobile - Primary ID 00816063022121
Device Regulatory Overview
The iTero Lumina Pro Mobile (Model/Catalog Number: 217612) is a medical device manufactured by Align Technology Ltd.. This product is indexed under FDA Product Code / Category Classification Q010207 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 217612
- Product Code / EMDN
- Q010207
- Device Name
- iTero Lumina™ Pro / iTero Lumina™ Pro Mobile
- Database Sync Date
- 2026-08-09 16:30:18
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 Lumina Pro Mobile?
The registered manufacturer of record for iTero Lumina Pro Mobile is Align Technology Ltd..
What is the Primary UDI-DI identifier for iTero Lumina Pro Mobile?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00816063022121.
What classification code is assigned to this device?
This device is registered under product classification code Q010207.
Similar Classification Devices (Q010207)
Other Devices by Align Technology Ltd.
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