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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

A58250 — IVDR Class B IVDR by GeneProof a.s.

MD Atlas
GeneProof a.s.

EUDAMED last updated this device on May 25, 2026

A58250

859569630004Q9

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GeneProof a.s.
UDI-DI code: 08595696305093
Reference / catalog number: A58250

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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: 08595696305093
Basic UDI-DI: 859569630004Q9
Reference / catalog number: A58250
Issuing entity: GS1

Classification

Risk category: IVDR Class B
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 kit is intended for use as an accessory for an in vitro diagnostic medical device. The GeneProof Universal Internal Control presents internal control for the whole diagnostic process, i.e. DNA/RNA extraction efficiency, reverse-transcription step efficiency (transcription of RNA into cDNA) and PCR amplification efficiency (PCR inhibition). Device is intended to be used as a control material without quantitative or qualitative assigned values. The product is intended for use in combination with manual and/or automated extraction from various clinical specimens: whole blood, CSF, plasma, serum, urine, BAL, swab. The GeneProof Universal Internal Control is intended for use as a complementary product for all GeneProof microbiology portfolio kits. The intended users are trained professionals in clinical laboratories and hospitals.
Additional information URL: https://thermofisher.com/geneproofIFU
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105080807MULTICONSTITUENT CONTROLS - INF.IMM.

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

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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.