GUDIDData
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eudamed_udi Primary ID: 00884838129542

CT Areta RT (UDI 00884838129542)

Manufactured by Philips Healthcare (Suzhou) Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CT Areta RT - Primary ID 00884838129542

Device Regulatory Overview

The CT Areta RT (Model/Catalog Number: 728382) is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification Z11030605 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-1003-2026 View Full Alert →

Philips Incisive CT...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1273-2021 View Full Alert →

Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) appli...

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ID: Z-0640-2024 View Full Alert →

Incisive CT, model 728143 & 728144 running Software Version 5.0.0....

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Technical Specifications

Model Number
728382
Product Code / EMDN
Z11030605
Device Name
CT Scanner System (CT Rembra RT/CT Areta RT/CT Rembra)
Database Sync Date
2026-08-09 19:05:49

Full Regulatory Attributes

🔒 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 CT Areta RT?

The registered manufacturer of record for CT Areta RT is Philips Healthcare (Suzhou) Co., Ltd..

What is the Primary UDI-DI identifier for CT Areta RT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00884838129542.

What classification code is assigned to this device?

This device is registered under product classification code Z11030605.

Similar Classification Devices (Z11030605)

Other Devices by Philips Healthcare (Suzhou) Co., Ltd.

Programmatic Export

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

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