GUDIDData
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eudamed_udi Primary ID: 00884838082243

MX40 - 2.4 (UDI 00884838082243)

Manufactured by Philips Medical Systems

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MX40 - 2.4 - Primary ID 00884838082243

Device Regulatory Overview

The MX40 - 2.4 (Model/Catalog Number: 865351) is a medical device manufactured by Philips Medical Systems. This product is indexed under FDA Product Code / Category Classification Z12050803 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0745-2016 View Full Alert →

DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621...

πŸ”’ Compromised Lot & Serial Numbers Locked
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ID: Z-0010-2017 View Full Alert →

Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body...

πŸ”’ Compromised Lot & Serial Numbers Locked
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ID: Z-0012-2017 View Full Alert →

Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body...

πŸ”’ Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
865351
Product Code / EMDN
Z12050803
Device Name
MX40 Patient Wearable Monitor
Database Sync Date
2026-08-09 16:29:25

Full Regulatory Attributes

πŸ”’ Token Gated 
{
    "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 MX40 - 2.4?

The registered manufacturer of record for MX40 - 2.4 is Philips Medical Systems.

What is the Primary UDI-DI identifier for MX40 - 2.4?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00884838082243.

What classification code is assigned to this device?

This device is registered under product classification code Z12050803.

Similar Classification Devices (Z12050803)

Other Devices by Philips Medical Systems

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

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