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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

A58117 — IVDR Class C IVDR by GeneProof a.s.

MD Atlas
GeneProof a.s.

EUDAMED last updated this device on May 14, 2026

A58117

859569630012Q8

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: 08595696303952
Reference / catalog number: A58117

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Manufacturer information

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

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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.

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: 08595696303952
Basic UDI-DI: 859569630012Q8
Reference / catalog number: A58117
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. Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma genitalium infection can cause cervicitis, urethritis, and proctitis. In women, chlamydial and gonorrhoea infection can cause pelvic inflammatory disease, tubal factor infertility, ectopic pregnancy, and chronic pelvic pain. Infants of mothers with chlamydial and gonorrhoea infection can contract neonatal conjunctivitis, which may lead to blindness. The GeneProof CT/NG/MG Multiplex PCR Kit is an in vitro nucleic acid amplification test intended for detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium by real-time polymerase chain reaction (PCR) method. The clinical specimens used for the detection are swabs and urine. The GeneProof CT/NG/MG 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 detection. The kit is intended for diagnostics an 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

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