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EUDAMED last updated this device on Jun 26, 2026
084535700358A2[0358P] KWIK-STIK™ B. fragilis NCTC 9343 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Microbiologics, INC.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
20845357007524[0358P] KWIK-STIK™ B. fragilis NCTC 9343(01)20845357007524
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01040601QC STRAINS BACTERIOLOGY1 warning recorded — scroll inside the panel to see all entries.
Primary placement in France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
US-MF-000000466The 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.084535708206B2On the market[0164K] KWIK-STIK™ C. shigense ATCC 51823™0845357001649KOn the market[0522P] KWIK-STIK™ M. avium (1) ATCC 15769™0845357005229POn the market[0626U] KWIK-STIK™ K. oxytoca ATCC 49131™084535700626A4On the market[01104U] KWIK-STIK™ E. coli (O104:H4) ATCC BAA-2326™0845357001104W5On the market[01103K] KWIK-STIK™ S. Enteritidis ATCC 49223™0845357001103W3On the marketNo certificate specifically references this device's Basic UDI-DI.