gudid Primary ID: Fenom Pro, Australia/New Zealand

CAIRE Diagnostics (UDI Fenom Pro, Australia/New Zealand)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The CAIRE Diagnostics (Model/Catalog Number: Fenom Pro, Australia/New Zealand) 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, Australia/New Zealand
Product Code / EMDN: MXA
Device Name: Package contains:Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for Australia/New ZealandAC Power Cord Cable, Australia/New Zealand - PN 415-0010
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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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, Australia/New Zealand.

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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