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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

A58128 — IVDD — General IVDD by GeneProof a.s.

MD Atlas
GeneProof a.s.

EUDAMED last updated this device on May 25, 2026

A58128

B-08595696304065

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: 08595696304065
Reference / catalog number: A58128

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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: 08595696304065
Basic UDI-DI: B-08595696304065
Reference / catalog number: A58128
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: The kit is an in vitro nucleic acid amplification test intended for measurement and detection of Herpes simplex viruses (HSV-1 and HSV-2) from clinical specimens: CSF, plasma, serum, urine, swab and whole blood. The kit can be used in combination with a manual or automated extraction system. The kit is designed for human in vitro diagnostics and provides both qualitative and quantitative detection. The kit is intended for diagnostics, aid to diagnosis or monitoring test and it is designed for professional use in laboratories with trained personnel. The intended testing population are immunocompromised patients, symptomatic sexually active individuals and patients with neuroinfections, infections of eye and skin and exanthematous diseases. The target population is the EU population.
Additional information URL: https://thermofisher.com/geneproofIFU
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105040311HSV - 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

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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.