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EUDAMED last updated this device on Nov 22, 2023
590470802014PD90LWSalmonella Shigella Agar/Hektoen Enteric Agar 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.
059047080013122014PD902 packaging levels registered — each level carries its own UDI-DI.
05904708001312× 1 unitBase unit05904708008922× 10 units05904708008939× 2 units(01)05904708001312
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104010407BI-PLATES - INCLUDING NON-CHROMOGENIC & CHROMOGENIC MEDIA COMBINATION1 warning recorded — scroll inside the panel to see all entries.
PL-MF-000022437The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Poland; available across 1 country total.
Placed on the market in Poland; per-country availability dates not published.
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 certificate specifically references this device's Basic UDI-DI.
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.590470801250PD90MMOn the marketSalmonella Shigella Agar590470803018BT100P9On the marketSalmonella Shigella Agar/Bismuth Sulphite Agar (Wilson Blair)590470802037PD90NROn the marketSalmonella Shigella Agar/XLD Agar590470802025PD90MNOn the marketSalmonella Shigella Agar/XLD Agar590470802025PD90MNOn the marketSchaedler Agar + 5% Sheep Blood590470801200PD90KLOn the market