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Follicle Stimulating Hormone Assay kit(Chemiluminescence Immunoassay Method）

by Shenzhen Dake Medical Technology Co., Ltd EUDAMED

Active European Union

Ref 100 testsModel 25 tests，50 tests，2×50 tests，100 tests，2×100 tests

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697846523HormoneB08J5 Basic UDI-DIDate25 May 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  • Withdrawn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

Trade Name
Follicle Stimulating Hormone Assay kit(Chemiluminescence Immunoassay Method）
Thyroid Stimulating Hormone Assay kit(Chemiluminescence Immunoassay Method）
Model / Reference
25 tests，50 tests，2×50 tests，100 tests，2×100 tests, 100 tests
Primary DI / UDI-DI
06978465237771, 06978465237443
Basic UDI-DI
697846523HormoneB08J5, 697846523HormoneB05HX
EMDN Code
W0102050104, W01020410
Device Class
Class B
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047336
Authorised representative
HyperCert Limited B.V. NL-AR-000047746

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No