eudamed_udi
Primary ID: 08432229102098
Unidix (UDI 08432229102098)
Manufactured by Karex Industries Sdn. Bhd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unidix - Primary ID 08432229102098
Device Regulatory Overview
The Unidix (Model/Catalog Number: KX-07) is a medical device manufactured by Karex Industries Sdn. Bhd.. This product is indexed under FDA Product Code / Category Classification Z11040185 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- KX-07
- Product Code / EMDN
- Z11040185
- Device Name
- Non-Sterile Natural Rubber Latex Protective Transducer Covers
- Database Sync Date
- 2026-08-09 16:29:34
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 Unidix?
The registered manufacturer of record for Unidix is Karex Industries Sdn. Bhd..
What is the Primary UDI-DI identifier for Unidix?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08432229102098.
What classification code is assigned to this device?
This device is registered under product classification code Z11040185.
Similar Classification Devices (Z11040185)
Other Devices by Karex Industries Sdn. Bhd.
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