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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

3250-050 — IVDR Class C IVDR by GENERI BIOTECH s.r.o.

MD Atlas
GENERI BIOTECH s.r.o.

EUDAMED last updated this device on Mar 30, 2026

3250-050

85952239000019XF

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GENERI BIOTECH s.r.o.
UDI-DI code: 08595223925022
Reference / catalog number: 3250-050

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Manufacturer information

Organization name: GENERI BIOTECH s.r.o.
SRN: CZ-MF-000018857
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
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
Poland		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08595223925022
Basic UDI-DI: 85952239000019XF
Reference / catalog number: 3250-050
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: INTENDED PURPOSE: The gb PHARM Warfarin in vitro diagnostic kit is intended for the qualitative determination of status (genotyping) of the rs1799853 (CYP2C9*2), rs1057910 (CYP2C9*3) and rs9923231 (VKORC1*3A) polymorphisms of human genes CYP2C9 and VKORC1, encoding cytochrome P450 2C9 precursor and vitamin K epoxide reductase complex subunit 1. The detection of these polymorphisms serves as an aid to identify patients at risk of adverse events or drug sensitivity when using coumarin-type anticoagulants. The detection is performed from human genomic DNA samples extracted from peripheral blood. The device is intended for testing in Caucasian population. It is intended for laboratory professional use by trained healthcare professionals. The kit requires manual preparation of reagents and samples, which are then analysed with the use of real-time PCR cycler instrument.
Additional information URL: https://www.generi-biotech.com/download/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0106010499POLYMORPHISM TESTS - OTHER

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

3219-025B-08595223921918On the market 3254-02585952239000016X9On the market 3254-05085952239000016X9On the market 3255-05085952239000020WYOn the market 3255-02585952239000020WYOn 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.