gudid
Primary ID: 1
CustoMed (UDI 1)
Manufactured by KENPAX INTERNATIONAL LIMITED
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CustoMed - Primary ID 1
Device Regulatory Overview
The CustoMed (Model/Catalog Number: 1) is a medical device manufactured by KENPAX INTERNATIONAL LIMITED. This product is indexed under FDA Product Code / Category Classification LYU within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1
- Product Code / EMDN
- LYU
- Device Name
- Gown Reinforced Chest & Sleeve
- Database Sync Date
- 2026-08-09 09:16:45
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 CustoMed?
The registered manufacturer of record for CustoMed is KENPAX INTERNATIONAL LIMITED.
What is the Primary UDI-DI identifier for CustoMed?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1.
What classification code is assigned to this device?
This device is registered under product classification code LYU.
Similar Classification Devices (LYU)
Other Devices by KENPAX INTERNATIONAL LIMITED
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