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FSH Menopause Rapid Tests

by Hangzhou Clongene Biotech Co., Ltd. EUDAMED

Active European Union

Ref WFSH1001 WFSH1002 WFSH1003Model WFSH1001 WFSH1002 WFSH1003

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-WFSH1007D Basic UDI-DIDate6 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
WFSH1001 WFSH1002 WFSH1003
Primary DI / UDI-DI
D-WFSH1007D
Basic UDI-DI
B-WFSH1007D
EMDN Code
W0102160301 Fsh - rt & poc
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000030069
Authorised representative
HUMISS TRADING S. L. ES-AR-000040177

Other devices from Hangzhou Clongene Biotech Co., Ltd.

See all devices from Hangzhou Clongene Biotech Co., Ltd. →

Properties

  • 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