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EUDAMED last updated this device on Jun 16, 2026
B-08594161958512GeneProof Factor V Leiden MC PCR Kit is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by GeneProof a.s.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08594161958512FV/MC/200(01)08594161958512
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0106010103FACTOR V LEIDEN1 warning recorded — scroll inside the panel to see all entries.
CW010CZ-MF-000002370Primary placement in Czechia; available across 4 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
| Germany | — | Still on market |
| Poland | — | Still on market |
| Slovakia | — | Still on market |
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
B-08594161958505On the marketGeneProof Factor II Prothrombin PCR KitB-08594161956969On the marketGeneProof Factor II Prothrombin PCR KitB-08594161955122On the marketGeneProof Factor V Leiden MC PCR KitB-08595696302702On the marketGeneProof Factor V Leiden PCR KitB-08594161956976On the marketGeneProof Factor V Leiden PCR KitB-08594161955023On the marketNo 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.