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STANDARD™ i fT4

by SD Biosensor Inc. South Korea EUDAMED

Ref 16FT410FModel i-fT4-01 EMDN W01020402

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88001117IPBA01IA19WC Basic UDI-DIDate16 Jul 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  • Withdrawn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
i-fT4-01, 16FT410F
Primary DI / UDI-DI
08800111723377
Basic UDI-DI
88001117IPBA01IA19WC
EMDN Code
W01020402 Free thyroxine
Device Class
Class B
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
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 8a602dc3-66ae-4054-880e-67c72ea7debd 61 fields · synced 24 Oct 2026