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EUDAMED last updated this device on Dec 13, 2023
590470803122BT100MXFalcow Decarboxylase Broth + Lysine 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.
059047080026613122BT2001 packaging level registered — each level carries its own UDI-DI.
05904708002661× 1 unitBase unit05904708011304× 10 units(01)05904708002661
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104010306CULTURE MEDIA IN BOTTLESW0104080299MANUAL IDENTIFICATION - OTHER1 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 →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 →No certificate specifically references this device's Basic UDI-DI.
590470803123BT100NCOn the marketFalcow Decarboxylase Broth + Lysine590470803122BT100MXOn the marketFalcow Decarboxylase Broth + Lysine590470803122BT100MXOn the marketFalcow Decarboxylase Broth + Lysine590470806129TBWROn the marketFalcow Decarboxylase Broth + Ornithine590470806131TBVQOn the marketFalcow Decarboxylase Broth + Ornithine590470803124BT100NROn the market