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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

LAB — IVDR Class A IVDR by GenomeUp

MD Atlas
GenomeUp

EUDAMED last updated this device on May 26, 2026

LAB

805889800LAB-A-001SU

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GenomeUp
UDI-DI code: 80588980000488
Reference / catalog number: LAB

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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.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 80588980000488
Basic UDI-DI: 805889800LAB-A-001SU
Reference / catalog number: LAB
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: Software per l’elaborazione bioinformatica di dati genomici derivati da sequenziamento NGS e la gestione strutturata degli output associati. Funzioni limitate al supporto tecnico-operativo dei processi di laboratorio, senza interpretazione diagnostica dei dati. Per uso professionale.
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)80588980000488

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EMDN nomenclature code(s)

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

W02079092VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.