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EUDAMED last updated this device on Nov 9, 2023
590470801402PD90MCCHROMagar MRSA is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by GRASO Zenon Sobiecki. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
059047080009262014024 packaging levels registered — each level carries its own UDI-DI.
05904708000926× 1 unitBase unit05904708007819× 10 units05904708007826× 20 units05904708007833× 100 units05904708007840× 240 units(01)05904708000926
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104010402CHROMOGENIC ID MEDIA (PLATES)W0104010404CHROMOGENIC RESISTANCE MARKER MEDIA (PLATES) - MRSA, VRE, ESBL …1 warning recorded — scroll inside the panel to see all entries.
Primary placement in Poland; available across 1 country total.
Placed on the market in Poland; per-country availability dates not published.
PL-MF-000022437The 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 →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 →590470801471PD90PUOn the marketCHROMagar LIN-R590470801476PD90RKOn the marketCHROMagar LIN-R590470801476PD90RKOn the marketCHROMagar MRSA590470801402PD90MCOn the marketCHROMagar MRSA/Columbia Agar + 5% Sheep Blood590470802074PD90PCOn the marketCHROMagar MRSA/Columbia CNA + 5% Sheep Blood590470802077PD90QDOn 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.No certificate specifically references this device's Basic UDI-DI.