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KWIK-STIK™ and LYFO DISK™

by Microbiologics, INC. United States EUDAMED

Ref [0619K] KWIK-STIK™ B. uniformis ATCC 8492™Model 0619

EMDN W01040601

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number084535700619A7 Basic UDI-DIDate20 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
KWIK-STIK™ and LYFO DISK™
Model / Reference
0619, [0619K] KWIK-STIK™ B. uniformis ATCC 8492™
Primary DI / UDI-DI
30845357014604
Basic UDI-DI
084535700619A7
EMDN Code
W01040601 Qc strains bacteriology
Device Class
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000000466
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

Related devices

Category: Multiple bacteria species culture isolate identification control IVD, kit

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Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED edfd1dce-3b9f-4215-9a84-4947bd235344 61 fields · synced 22 Oct 2026