GUDIDData
Bulk Audit Tool API Access
eudamed_udi Primary ID: 00884838059849

Access CT (UDI 00884838059849)

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 Access CT - Primary ID 00884838059849

Device Regulatory Overview

The Access CT (Model/Catalog Number: 728116) is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification Z11030603 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...

🔒 Compromised Lot & Serial Numbers Locked
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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
728116
Product Code / EMDN
Z11030603
Device Name
CT Scanner System (Access CT)
Database Sync Date
2026-08-09 16:29:07

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

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Frequently Asked Questions

Who is the primary manufacturer of Access CT?

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

What is the Primary UDI-DI identifier for Access CT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00884838059849.

What classification code is assigned to this device?

This device is registered under product classification code Z11030603.

Similar Classification Devices (Z11030603)

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

Programmatic Export

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

JSON API Endpoint