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Organization name
UDI-DI code
Reference / catalog number

09120127730244 — IVDR Class A IVDR by Cube Dx GmbH

MD Atlas
Cube Dx GmbH

EUDAMED last updated this device on Apr 14, 2026

09120127730244

912012773GINA7H

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Cube Dx GmbH
UDI-DI code: 09120127730244
Reference / catalog number: 09120127730244

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Manufacturer information

Organization name: Cube Dx GmbH
SRN: AT-MF-000013909
Manufacturer status: Active

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Critical warnings

7 warnings recorded — scroll inside the panel to see all entries.

CW057
EUDAMED did not publish a description for this code.
CW082
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW139
EUDAMED did not publish a description for this code.
CW148
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW416
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 09120127730244
Basic UDI-DI: 912012773GINA7H
Reference / catalog number: 09120127730244
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: 100
Additional product description: Pathogen enrichment and lysis kit for 500μL samples. Contains 100 reactions. DNA purification not included. CE-IVD.
Additional information URL: https://www.cubedx.com/en/support
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02050106DNA GENOMIC PREPARATION DEVICES

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

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.