eudamed_udi
Primary ID: 04719882150197
Leltek (UDI 04719882150197)
Manufactured by Leltek Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Leltek - Primary ID 04719882150197
Device Regulatory Overview
The Leltek (Model/Catalog Number: LX128LC) 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
- LX128LC
- Product Code / EMDN
- Z11040106
- Device Name
- Diagnostic Ultrasound Imaging System
- Database Sync Date
- 2026-08-09 16:29:02
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 Leltek?
The registered manufacturer of record for Leltek is Leltek Inc..
What is the Primary UDI-DI identifier for Leltek?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04719882150197.
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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