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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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Organization name
UDI-DI code
Reference / catalog number

9002813 — IVDR Class A IVDR by QIAGEN GmbH

MD Atlas
QIAGEN GmbH

EUDAMED last updated this device on Apr 28, 2026

9002813

4053228IQSTA00000000001VT

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: QIAGEN GmbH
UDI-DI code: 04053228033936
Reference / catalog number: 9002813

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Manufacturer information

Organization name: QIAGEN GmbH
SRN: DE-MF-000004949
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Hungary; available across 2 countries total.

Country	On market since	Until
HungaryPrimary placement		Still on market
Netherlands		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04053228033936
Basic UDI-DI: 4053228IQSTA00000000001VT
Reference / catalog number: 9002813
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The QIAstat-Dx Analyzer platform is intended as an in vitro diagnostic device for use with QIAstat-Dx assays and provides full automation from sample preparation to real-time PCR detection for molecular applications.
Additional information URL: https://www.qiagen.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02050116NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.