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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

JuliaOmix™ TRK — IVDR Class A IVDR by GenomeUp

MD Atlas
GenomeUp

EUDAMED last updated this device on Sep 11, 2025

JuliaOmix™ TRK

805889800JO-TRK-0015Z

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GenomeUp
UDI-DI code: 80588980000174
Reference / catalog number: TRK

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View device family (Basic UDI)

Manufacturer information

Organization name: GenomeUp
SRN: IT-MF-000046537
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: JuliaOmix™ TRK
UDI-DI code: 80588980000174
Basic UDI-DI: 805889800JO-TRK-0015Z
Reference / catalog number: TRK
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: The JuliaOmix™ TRK module is a software component intended to support qualified personnel in the tracking and operational management of laboratory samples. Its functions are limited to the administrative and operational traceability of test requests and associated samples, including registration, identification, workflow status monitoring, and documentation of non-conformities. The software does not analyse biological samples, does not perform diagnostic interpretation, and does not provide clinical decision support.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)80588980000174

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W02069082VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Related devices

JuliaOmix™ CLD805889800JO-CLD-001Q2On the market LAB805889800LAB-A-001SUOn the market JuliaOmix™ MED805889800JO-MED-001SHOn 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.