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eudamed_udi Primary ID: 04056869001395

Biograph mCT Flow 40-3R (UDI 04056869001395)

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 Flow 40-3R - Primary ID 04056869001395

Device Regulatory Overview

The Biograph mCT Flow 40-3R (Model/Catalog Number: 10529158) 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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🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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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
10529158
Product Code / EMDN
Z11020301
Device Name
PET-CT_11_IIb_HES
Database Sync Date
2026-08-09 16:49:00

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 Flow 40-3R?

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

What is the Primary UDI-DI identifier for Biograph mCT Flow 40-3R?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04056869001395.

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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