gudid
Primary ID: Fenom Pro, US
CAIRE Diagnostics (UDI Fenom Pro, US)
Manufactured by Caire Diagnostics Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CAIRE Diagnostics - Primary ID Fenom Pro, US
Device Regulatory Overview
The CAIRE Diagnostics (Model/Catalog Number: Fenom Pro, US) is a medical device manufactured by Caire Diagnostics Inc.. This product is indexed under FDA Product Code / Category Classification MXA within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Fenom Pro, US
- Product Code / EMDN
- MXA
- Device Name
- Package contains:Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for USInstructions for Use, Fenom Pro, US Configuration - P/N IFU-3393AC Power Cord Cable, US - PN 415-0003
- Database Sync Date
- 2026-08-09 09:49:17
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 CAIRE Diagnostics?
The registered manufacturer of record for CAIRE Diagnostics is Caire Diagnostics Inc..
What is the Primary UDI-DI identifier for CAIRE Diagnostics?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Fenom Pro, US.
What classification code is assigned to this device?
This device is registered under product classification code MXA.
Similar Classification Devices (MXA)
Other Devices by Caire Diagnostics Inc.
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