eudamed_udi
Primary ID: 04719882152122
ASUS (UDI 04719882152122)
Manufactured by Leltek Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ASUS - Primary ID 04719882152122
Device Regulatory Overview
The ASUS (Model/Catalog Number: LU800L) is a medical device manufactured by Leltek Inc.. This product is indexed under FDA Product Code / Category Classification Z11040106 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- LU800L
- Product Code / EMDN
- Z11040106
- Device Name
- Diagnostic Ultrasound Imaging System
- Database Sync Date
- 2026-08-09 16:47:08
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 ASUS?
The registered manufacturer of record for ASUS is Leltek Inc..
What is the Primary UDI-DI identifier for ASUS?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04719882152122.
What classification code is assigned to this device?
This device is registered under product classification code Z11040106.
Similar Classification Devices (Z11040106)
Other Devices by Leltek Inc.
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