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EUDAMED last updated this device on Dec 8, 2023
590470806152TBWB2% Sodium Deoxycholate 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.
059047080044056152TB21 packaging level registered — each level carries its own UDI-DI.
05904708004405× 1 unitBase unit05904708012486× 50 units(01)05904708004405
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104080299MANUAL 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 →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.
590470806136TBWHOn the market1% Peptone Water + Tryptophane590470803117BT100PFOn the market1% Peptone Water + Tryptophane590470806136TBWHOn the market6,5% Sodium Chloride Broth590470803121BT100MJOn the marketAzide Blood Agar + Crystal Violet590470801112PD90L6On the marketBacillus Subtilis Agar59047080TN2115F3On 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.