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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

PurePrep Path DX Kit (480 rxn) — IVDR Class A IVDR

MD Atlas
IST Innuscreen GmbH

EUDAMED last updated this device on Jun 30, 2025

PurePrep Path DX Kit (480 rxn)

4262375220048P

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: IST Innuscreen GmbH
UDI-DI code: 04262375224054
Reference / catalog number: MGV000484

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Manufacturer information

Organization name: IST Innuscreen GmbH
SRN: DE-MF-000024606
Manufacturer status: Active

Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: PurePrep Path DX Kit (480 rxn)
UDI-DI code: 04262375224054
Basic UDI-DI: 4262375220048P
Reference / catalog number: MGV000484
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: Kit for automated isolation and purification of viral nucleic acids from cell-free body fluids including an IC DNA/RNA
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01019001BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
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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.