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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

A58127 — IVDD — General IVDD by GeneProof a.s.

MD Atlas
GeneProof a.s.

EUDAMED last updated this device on May 25, 2026

A58127

B-08595696304058

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: GeneProof a.s.
UDI-DI code: 08595696304058
Reference / catalog number: A58127

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Manufacturer information

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

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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.

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: 08595696304058
Basic UDI-DI: B-08595696304058
Reference / catalog number: A58127
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Kit is intended for qualitative diagnostics and aid to diagnosis of Ureaplasma parvum and Ureaplasma urealyticum from swab and urine by Polymerase Chain Reaction (PCR) method. The intended users are professional personnel of clinical laboratories.
Additional information URL: https://thermofisher.com/geneproofIFU
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105011699BACTERIOLOGY - NA REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification