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EUDAMED last updated this device on Nov 22, 2023
590470802019PD90NMCHROMagar VRE/CHROMagar KPC 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.
059047080013362019PD902 packaging levels registered — each level carries its own UDI-DI.
05904708001336× 1 unitBase unit05904708008960× 10 units05904708008977× 2 units(01)05904708001336
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104010407BI-PLATES - INCLUDING NON-CHROMOGENIC & CHROMOGENIC MEDIA COMBINATIONW0104010404CHROMOGENIC 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 →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.590470801007PD90LXOn the marketCHROMagar VRE590470801460PD90P4On the marketCHROMagar VRE590470801460PD90P4On the marketCHROMagar VRE/CHROMagar MRSA590470802033PD90MDOn the marketCHROMagar Y. enterocolitica590470801484PD90RAOn the marketCHROMagar Y. enterocolitica590470801484PD90RAOn the marketNo certificate specifically references this device's Basic UDI-DI.