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BACTEROMIC Panel UNI 2.0

by Bacteromic Spółka Z Ograniczoną Odpowiedzialnością Poland EUDAMED

Ref BQS-520011

EMDN W0104080113

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59047268494PanelUNI-2.0VQ Basic UDI-DIDate24 Feb 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

Model / Reference
BQS-520011
Primary DI / UDI-DI
05904726849484
Basic UDI-DI
59047268494PanelUNI-2.0VQ
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
  • New Device
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED aa4c1df5-cf3c-47ef-90a8-1d90e33c7fb3 61 fields · synced 22 Oct 2026