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BACTEROMIC Panel UNI FAST

by Bacteromic Spółka Z Ograniczoną Odpowiedzialnością Poland EUDAMED

Ref BQS-520014

EMDN W0104080113

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59047268494PanelFASTI32 Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
BACTEROMIC Panel UNI FAST (FAS01-I)
Model / Reference
BQS-520014
Primary DI / UDI-DI
05904726849415
Basic UDI-DI
59047268494PanelFASTI32
EMDN Code
W0104080113 Other automated susceptibility testing (incl consumables...)
Device Class
Class B
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000040114

Other devices from Bacteromic Spółka Z Ograniczoną Odpowiedzialnością

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 e5c83a87-9dd8-4d0a-9408-b549c5ed680d 61 fields · synced 24 Oct 2026