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Singclean®

by Hangzhou Singclean Medical Products Co., Ltd. 64 variants

Ref FSH-03-20tModel Strip, Cassette, Midstream

Singclean® (FSH-03-20t) is a Class B device made by Hangzhou Singclean Medical Products Co., Ltd., registered in EUDAMED on 30 Jul 2026 (Basic UDI-DI 69360201198Z), active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

30 Nov 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69360201198Z Basic UDI-DI 06936020109642UDI-DIDate30 Jul 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 823883 Active

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    1 Dec 2025
    Expires
    30 Nov 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Follicle Stimulating Hormone (FSH) Test Kit (Colloidal Gold)
Model / reference
Strip, Cassette, Midstream, FSH-03-20t
Primary DI / UDI-DI
06936020109642
Basic UDI-DI
69360201198Z
EMDN code
W0102160301 Fsh - rt & poc
Device class
Class B
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000014098
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Hangzhou Singclean Medical Products Co., Ltd.

See all devices from Hangzhou Singclean Medical Products Co., Ltd. →

Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Self-testing
  • Professional testing
Other properties (7, all answered No)