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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

A58123 — IVDR Class C IVDR by GeneProof a.s.

MD Atlas
GeneProof a.s.

EUDAMED last updated this device on May 20, 2026

A58123

859569630002Q5

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GeneProof a.s.
UDI-DI code: 08595696304010
Reference / catalog number: A58123

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Manufacturer information

Organization name: GeneProof a.s.
SRN: CZ-MF-000002370
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement		Still on market
Netherlands		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08595696304010
Basic UDI-DI: 859569630002Q5
Reference / catalog number: A58123
Issuing entity: GS1

Classification

Risk category: IVDR Class C
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 intended purpose of the device is related to the medical context and clinical conditions under which the device may be used. Mycoplasma hominis, Ureaplasma urealyticum and Ureaplasma parvum infection can cause bacterial vaginosis, pelvic inflammatory disease, cervicitis, cervical or vaginal discharge, endometritis, urethritis or chorioamnionitis in women. In men, infection can cause urethritis, prostatitis, epididymitis or infertility. The GeneProof MH/UU/UP Multiplex PCR Kit is an in vitro nucleic acid amplification test (multiplex) intended for detection of M. hominis, U. urealyticum and U. parvum bacteria from clinical specimens: swabs and urine. The GeneProof MH/UU/UP Multiplex PCR Kit can be used in combination with a manual or automated extraction system. The kit is designed for human in vitro diagnostics and provides qualitative and quantitative detection. The kit is intended for diagnostics and aid to diagnosis and it is designed for professional use in laboratories with trained staff.
Additional information URL: https://thermofisher.com/geneproofIFU
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105070501STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS

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

CGRT6/96859569630077R4On the market ADV/ISEX/025B-08594161952756On the market ADV/ISEX/100B-08594161952770On the market ASP/ISEX/100B-08594161952923On the market ASP/ISEX/025B-08594161952909On 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.