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Kromogeeninen ESBL agarmalja

by Tammer BioLab Oy Finland EUDAMED

Ref T245Model CHR-ESBL EMDN W0104010402

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06430080100538 Basic UDI-DIDate27 Sep 2024RegisteredStatusActive
European UnionCE/IVDD NumberB-06430080100538 Basic UDI-DIDate27 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
CHR-ESBL, T245
Primary DI / UDI-DI
06430080100538, 06430080100521
Basic UDI-DI
B-06430080100538, 643008010T245Y2
EMDN Code
W0104010402, W0104010404
Device Class
Class IVD General
Class A
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000010901

Other devices from Tammer BioLab Oy

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent NoEUDAMEDYesEUDAMED
  • Professional Testing
  • Surgical Instrument YesEUDAMEDNoEUDAMED
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (2)

  • EUDAMED f46b9846-c9df-4cc8-b12c-8cdcaa476d28 61 fields · synced 22 Oct 2026
  • EUDAMED 06430080100521|643008010T245Y2 61 fields · synced 24 Oct 2026