GUDIDData
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eudamed_udi Primary ID: 00842768005886

Dimension EMPTY Flex Reagent Cartridge (UDI 00842768005886)

Manufactured by Siemens Healthcare Diagnostics Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Dimension EMPTY Flex Reagent Cartridge - Primary ID 00842768005886

Device Regulatory Overview

The Dimension EMPTY Flex Reagent Cartridge (Model/Catalog Number: 10445039) is a medical device manufactured by Siemens Healthcare Diagnostics Inc.. This product is indexed under FDA Product Code / Category Classification W0201020185 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.
Unlock Lot Data ($49)

Technical Specifications

Model Number
10445039
Product Code / EMDN
W0201020185
Device Name
IVDR_67_GLA_DUB-C_A_INST_EMPTY
Database Sync Date
2026-08-09 18:46:08

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 Dimension EMPTY Flex Reagent Cartridge?

The registered manufacturer of record for Dimension EMPTY Flex Reagent Cartridge is Siemens Healthcare Diagnostics Inc..

What is the Primary UDI-DI identifier for Dimension EMPTY Flex Reagent Cartridge?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00842768005886.

What classification code is assigned to this device?

This device is registered under product classification code W0201020185.

Similar Classification Devices (W0201020185)

Other Devices by Siemens Healthcare Diagnostics Inc.

Programmatic Export

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