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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

09120127730763 — IVDD — General IVDD by Cube Dx GmbH

MD Atlas
Cube Dx GmbH

EUDAMED last updated this device on Apr 14, 2026

09120127730763

B-09120127730763

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Cube Dx GmbH
UDI-DI code: 09120127730763
Reference / catalog number: 09120127730763

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Manufacturer information

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

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: 09120127730763
Basic UDI-DI: B-09120127730763
Reference / catalog number: 09120127730763
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: PCR test kit for detection of bacterial resistance markers from isolated DNA. Contains 12 PCR reactions. DNA extraction 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)

W0105070203GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS

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.