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STANDARD™ F TB-Feron Control

by SD Biosensor Inc. South Korea EUDAMED

Ref 10TBFC20Model C-F-TBF-01 EMDN W0105080899

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88001117IPCA02FA25WG Basic UDI-DIDate1 Oct 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  • Withdrawn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 24 Oct 2026

Model / Reference
C-F-TBF-01, 10TBFC20
Primary DI / UDI-DI
08800111727405
Basic UDI-DI
88001117IPCA02FA25WG
EMDN Code
W0105080899 Controls - inf. immunology - other
Device Class
Class C
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000009168
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Sd Biosensor

See all devices from Sd Biosensor →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 08800111727405|88001117IPCA02FA25WG 61 fields · synced 24 Oct 2026