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eudamed_udi Primary ID: 04056869979861

Biograph mCT S(40) - 3R combination (UDI 04056869979861)

Manufactured by Siemens Medical Solutions USA, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Biograph mCT S(40) - 3R combination - Primary ID 04056869979861

Device Regulatory Overview

The Biograph mCT S(40) - 3R combination (Model/Catalog Number: 11521494) is a medical device manufactured by Siemens Medical Solutions USA, Inc.. This product is indexed under FDA Product Code / Category Classification Z11020301 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-3217-2024 View Full Alert →

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ID: Z-3215-2024 View Full Alert →

ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ul...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-3216-2024 View Full Alert →

ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software...

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

Technical Specifications

Model Number
11521494
Product Code / EMDN
Z11020301
Device Name
MDR_SPPP_11_IIb_HES_Comb.PET-CT
Database Sync Date
2026-08-09 17:14:40

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 Biograph mCT S(40) - 3R combination?

The registered manufacturer of record for Biograph mCT S(40) - 3R combination is Siemens Medical Solutions USA, Inc..

What is the Primary UDI-DI identifier for Biograph mCT S(40) - 3R combination?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04056869979861.

What classification code is assigned to this device?

This device is registered under product classification code Z11020301.

Similar Classification Devices (Z11020301)

Other Devices by Siemens Medical Solutions USA, Inc.

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