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EUDAMED last updated this device on Aug 7, 2025
594054037AGARCUBILASIR2QLAGAR CU BILA SI ROSU VIOLET 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.
0594054037035310168(01)05940540370353
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104010306CULTURE MEDIA IN BOTTLESPrimary placement in Romania; available across 1 country total.
Placed on the market in Romania; per-country availability dates not published.
RO-MF-000035897The 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.
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 →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.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 →594054037AGARCUBILAS456K4On the marketAGAR CU BILA SI ESCULINA (BILE ESCULINE AGAR)594054037AGARCUBILAS345JSOn the marketAGAR CU BILA SI ROSU VIOLET594054037AGARCUBILAS123J6On the marketAGAR CU CITRAT CHRISTENSEN (CHRISTENSEN CITRATE AGAR)594054037AGARCUCITRAT34VDOn the marketAGAR CU EXTRACT DE MALT (MALT EXTRACT AGAR)594054037AGARCUEXTRAC233TOn the marketAGAR CU EXTRACT DE MALT (MALT EXTRACT AGAR)594054037AGARCUEXTRAC123NOn the marketNo certificate specifically references this device's Basic UDI-DI.