- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Aug 18, 2025
594054037MEDIUFALKOWP23B3MEDIU FALKOW PENTRU DECARBOXILAZA (DECARBOXYLASE TEST MEDIUM BASE (FALKOW)) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Sanimed International Impex S.A.. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05940540372463400635RO-MF-000035897No 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.(01)05940540372463
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 Romania; available across 1 country total.
Placed on the market in Romania; per-country availability dates not published.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104010101DEHYDRATED CULTURE MEDIA (DCM)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.
594054037MEDIUDEMIFRA345COn the marketMEDIU ECD (ECD MUG AGAR)594054037MEDIUECDECD123PSOn the marketMEDIU ELLNERS (ELLNERES BROTH)594054037MEDIUELLNERS36MOn the marketMEDIU FLETCHER (FLETCHER LEPTOSPIRA MEDIUM BASE)594054037MEDIUFLETCHER2B9On the marketMEDIU FRASER & SUPLIMENT SELECTIVE DE IMBOGATIRE (FRASER SECONDARY ENRICHMENT BROTH BASE)594054037MEDIUFRASER1239COn the marketMEDIU FRASER & SUPLIMENT SELECTIVE DE IMBOGATIRE (FRASER SECONDARY ENRICHMENT BROTH BASE)594054037MEDIUFRASER2349NOn the market