eudamed_udi
Primary ID: 00816063022183
iTero Element Scanner Sleeve (UDI 00816063022183)
Manufactured by Align Technology Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for iTero Element Scanner Sleeve - Primary ID 00816063022183
Device Regulatory Overview
The iTero Element Scanner Sleeve (Model/Catalog Number: 221963) is a medical device manufactured by Align Technology Ltd.. This product is indexed under FDA Product Code / Category Classification Z12119085 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 221963
- Product Code / EMDN
- Z12119085
- Device Name
- iTero Element Scanner Sleeves
- Database Sync Date
- 2026-08-09 18:19:22
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 Element Scanner Sleeve?
The registered manufacturer of record for iTero Element Scanner Sleeve is Align Technology Ltd..
What is the Primary UDI-DI identifier for iTero Element Scanner Sleeve?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00816063022183.
What classification code is assigned to this device?
This device is registered under product classification code Z12119085.
Similar Classification Devices (Z12119085)
Other Devices by Align Technology Ltd.
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