Skip to content

Follicle Stimulating Hormone Chemiluminescence Immunoassay Kit

by Sansure Biotech Inc. 5 variants

Ref S2019E-200

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06955792737419 Basic UDI-DI 06955792737419UDI-DIDate6 Sep 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Follicle Stimulating Hormone Chemiluminescence Immunoassay Kit
Model / Reference
S2019E-200
Primary DI / UDI-DI
06955792737419
Basic UDI-DI
B-06955792737419
EMDN Code
W0102050104 Follicle stimulating hormone
Device Class
Class IVD General
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000011392
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Sansure Biotech Inc.

See all devices from Sansure Biotech Inc. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No