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gudid Primary ID: 11206256

Atellica IM LH (UDI 11206256)

Manufactured by Siemens Healthcare Diagnostics Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Atellica IM LH - Primary ID 11206256

Device Regulatory Overview

The Atellica IM LH (Model/Catalog Number: 11206256) is a medical device manufactured by Siemens Healthcare Diagnostics Inc.. This product is indexed under FDA Product Code / Category Classification CEP 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-2087-2016 View Full Alert →

Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) ...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2058-2014 View Full Alert →

Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0459-2016 View Full Alert →

Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with ...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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Technical Specifications

Model Number
11206256
Product Code / EMDN
CEP
Device Name
Luteinizing Hormone (LH) - Atellica IM - RGT - 550T
Database Sync Date
2026-08-09 09:32:41

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 Atellica IM LH?

The registered manufacturer of record for Atellica IM LH is Siemens Healthcare Diagnostics Inc..

What is the Primary UDI-DI identifier for Atellica IM LH?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 11206256.

What classification code is assigned to this device?

This device is registered under product classification code CEP.

Similar Classification Devices (CEP)

Other Devices by Siemens Healthcare Diagnostics Inc.

Programmatic Export

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

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