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Ferritin Reagent Kit

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

Ref FER6011Y, FER6012Y, FER6013Y, FER6014Y, FER6015Y, FER6011N, FER6012N, FER6013N, FER6014N, FER6015N EMDN W0102070102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-FER601AE Basic UDI-DIDate8 May 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  • Withdrawn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 25 Oct 2026

Model / Reference
FER6011Y, FER6012Y, FER6013Y, FER6014Y, FER6015Y, FER6011N, FER6012N, FER6013N, FER6014N, FER6015N
Primary DI / UDI-DI
D-FER601AE
Basic UDI-DI
B-FER601AE
EMDN Code
W0102070102 Ferritin
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 D-FER601AE|B-FER601AE 61 fields · synced 25 Oct 2026