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Kovacs Reagent (100ml)

by Pro-Lab Diagnostics UK United Kingdom EUDAMED

Ref PL.375Model Stains EMDN W0104080209

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number506047246Kovacs&SIndole3A Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Kovacs Reagent and Spot Indole Reagent
Model / Reference
Stains, PL.375
Primary DI / UDI-DI
50604724600048
Basic UDI-DI
506047246Kovacs&SIndole3A
Direct Marketing DI
50604724600048
EMDN Code
W0104080209 Manual identification kits - anaerobes, pathogens - other
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
GB-MF-000003833
Authorised representative
Advena Limited MT-AR-000000234

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Properties & raw data

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

Sources (1)

  • EUDAMED 50604724600048|506047246KOVACS&SINDOLE3A 61 fields · synced 25 Oct 2026