Skip to content

FT4 Free Thyroxine (CLIA)

by Hangzhou Aichek Medical Technology Co., Ltd. FDA registration: China EUDAMED

Ref FT4706-AE10Y, FT4706-AE10N, FT4706-AE20Y, FT4706-AE20N EMDN W01020402

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-FT4706-AE10Y3V Basic UDI-DIDate4 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
FT4706-AE10Y, FT4706-AE10N, FT4706-AE20Y, FT4706-AE20N
Primary DI / UDI-DI
D-FT4706-AE10Y3V
Basic UDI-DI
B-FT4706-AE10Y3V
EMDN Code
W01020402 Free thyroxine
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000028093
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Hangzhou Aichek Medical Technology Co., Ltd.

See all devices from Hangzhou Aichek Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 9b21cae2-4ed0-422e-b831-07b892d6cefb-1 61 fields · synced 22 Oct 2026