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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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QIAcuityDx Universal MasterMix Kit — 2 UDI-DI variants, IVDR

MD Atlas
QIAGEN GmbH

Data from EUDAMED, last updated May 23, 2026

QIAcuityDx Universal MasterMix Kit

4053228AUMMQCY000000001DS

2 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class A

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: QIAGEN GmbH

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 4053228AUMMQCY000000001DS
Device name: QIAcuityDx Universal MasterMix Kit
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: May 12, 2026

Manufacturer & authorised representative

Manufacturer

Name: QIAGEN GmbH
SRN: DE-MF-000004949
Country: Germany
Email: info@qiagen.com
Phone: +492103290

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KRE28M1DFS2XEQVGK8Q18BTF

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

26010104053228049418
26010204053228049432