Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

09120127730169 — IVDR Class A IVDR by Cube Dx GmbH

MD Atlas
Cube Dx GmbH

EUDAMED last updated this device on Apr 15, 2026

09120127730169

912012773IPCEV

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: 09120127730169
Reference / catalog number: 09120127730169

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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: 09120127730169
Basic UDI-DI: 912012773IPCEV
Reference / catalog number: 09120127730169
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: 25
Additional product description: Internal Process Control: solution of bacterial cells (frozen). Contains 25 control 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)

W0105080808ALL INFECTIOUS DISEASES CONTROLS - NAT

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

Related devices

09120127730244912012773GINA7HOn the market 09120127730145912012773GINA7HOn the market 09120127730053B-09120127730053On the market 09120127730060B-09120127730060On the market 09120127730077B-09120127730077On 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.