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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

A58426 — IVDD — Annex II List A IVDD by GeneProof a.s.

MD Atlas
GeneProof a.s.

EUDAMED last updated this device on May 25, 2026

A58426

B-08595696304331

On the marketIVDD — Annex II List A

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: GeneProof a.s.
UDI-DI code: 08595696304331
Reference / catalog number: A58426

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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: 08595696304331
Basic UDI-DI: B-08595696304331
Reference / catalog number: A58426
Issuing entity: GS1

Classification

Risk category: IVDD — Annex II List A
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 intended for qualitative and quantitative diagnostics, aid to diagnostics or monitoring of Hepatitis B virus (HBV) from plasma or serum by the real-time 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)

W0105020216HEPATITIS B VIRUS - 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.