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Organization name
UDI-DI code
Reference / catalog number

09120127730145 — IVDR Class A IVDR by Cube Dx GmbH

MD Atlas
Cube Dx GmbH

EUDAMED last updated this device on Apr 17, 2026

09120127730145

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: 09120127730145
Reference / catalog number: 09120127730145

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Manufacturer information

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

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09120127730244912012773GINA7HOn the market 09120127730053B-09120127730053On the market 09120127730060B-09120127730060On the market 09120127730077B-09120127730077On the market 09120127730015912012773HDR-001XDOn the market

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.

Critical warnings

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

CW057
EUDAMED did not publish a description for this code.
CW076
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.
CW091
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.
CW159
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW444
EUDAMED did not publish a description for this code.
CW430
EUDAMED did not publish a description for this code.
CW397
EUDAMED did not publish a description for this code.
CW416
EUDAMED did not publish a description for this code.
CW300
EUDAMED did not publish a description for this code.
CW304
EUDAMED did not publish a description for this code.
CW150
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: 09120127730145
Basic UDI-DI: 912012773GINA7H
Reference / catalog number: 09120127730145
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: 50
Additional product description: Pathogen enrichment and lysis kit including DNA purification (spin columns) for 500μL samples. Contains 50 reactions. 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

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Software identification