eudamed_udi
Primary ID: 00726893117983
MyONE® Custom Fit™ (UDI 00726893117983)
Manufactured by Karex Industries Sdn. Bhd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MyONE® Custom Fit™ - Primary ID 00726893117983
Device Regulatory Overview
The MyONE® Custom Fit™ (Model/Catalog Number: MY-69L-336) is a medical device manufactured by Karex Industries Sdn. Bhd.. This product is indexed under FDA Product Code / Category Classification U110101 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- MY-69L-336
- Product Code / EMDN
- U110101
- Device Name
- Non-sterile, Non-medicated Natural Rubber Latex Male Condoms
- Database Sync Date
- 2026-08-09 16:28:51
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 MyONE® Custom Fit™?
The registered manufacturer of record for MyONE® Custom Fit™ is Karex Industries Sdn. Bhd..
What is the Primary UDI-DI identifier for MyONE® Custom Fit™?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00726893117983.
What classification code is assigned to this device?
This device is registered under product classification code U110101.
Similar Classification Devices (U110101)
Other Devices by Karex Industries Sdn. Bhd.
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