eudamed_udi
Primary ID: 15065023763389
TruVue (UDI 15065023763389)
Manufactured by BioFynder Limited
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for TruVue - Primary ID 15065023763389
Device Regulatory Overview
The TruVue (Model/Catalog Number: TV10039) is a medical device manufactured by BioFynder Limited. This product is indexed under FDA Product Code / Category Classification W0104080506 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- TV10039
- Product Code / EMDN
- W0104080506
- Device Name
- Carbapenem Resistant Enterobacteriaceae assay (LFA)
- Database Sync Date
- 2026-08-09 17:37:10
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 TruVue?
The registered manufacturer of record for TruVue is BioFynder Limited.
What is the Primary UDI-DI identifier for TruVue?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 15065023763389.
What classification code is assigned to this device?
This device is registered under product classification code W0104080506.
Similar Classification Devices (W0104080506)
Other Devices by BioFynder Limited
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