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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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QIAstat-Dx Analyzer 1.0; QIAstat-Dx… — 3 UDI-DI variants, IVDR

MD Atlas
QIAGEN GmbH

Data from EUDAMED, last updated May 23, 2026

QIAstat-Dx Analyzer 1.0; QIAstat-Dx Analyzer 2.0

4053228IQSTA00000000001VT

3 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

Professional testing

Identity & classification

Basic UDI-DI: 4053228IQSTA00000000001VT
Device name: QIAstat-Dx Analyzer 1.0; QIAstat-Dx Analyzer 2.0
Device model: QIAstat-Dx Analyzer
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Apr 28, 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

3 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KQ9QVK7ED3027VEJYXXZDXCA

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

900281404053228033929
900281304053228033936
900282604053228047582