- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 27, 2026
B-08594161958222GeneProof Gardnerella vaginalis 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.
08594161958222GV/GP/025CZ-MF-000002370(01)08594161958222
1 warning recorded — scroll inside the panel to see all entries.
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.
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.
Primary placement in Czechia; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
| Cyprus | — | Still on market |
| Germany | — | Still on market |
| Italy | — | Still on market |
| Lithuania | — | Still on market |
| Netherlands | — | Still on market |
| Slovakia | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105011699BACTERIOLOGY - NA REAGENTS - OTHERPrimary 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-08595696302399On the marketGeneProof Gardnerella vaginalis MC PCR KitB-08595696302382On the marketGeneProof Gardnerella vaginalis PCR KitB-08594161958246On the marketGeneProof Hepatitis B Virus (HBV) PCR KitB-08594161952015On the marketGeneProof Hepatitis B Virus (HBV) PCR KitB-08594161952039On the marketGeneProof Hepatitis C Virus (HCV) Diagnostic PCR KitB-08594161956914On 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.