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Follicle­Stimulating Hormone Test (25mIU)

by Assure Tech. (Hangzhou) Co., Ltd.

Ref A01310225Model Device, Strip, Midstream

Active European Union

CE IVDR

Valid until

1 Sep 2029

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69528048A058100YV Basic UDI-DI 06952804837877UDI-DIDate28 Aug 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2279233CE01 Active Supplemented

    Quality management system EU IVDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    10 Sep 2024
    Expires
    1 Sep 2029
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Follicle­Stimulating Hormone Test (25mIU)
Model / Reference
Device, Strip, Midstream, A01310225
Primary DI / UDI-DI
06952804837877
Basic UDI-DI
69528048A058100YV
EMDN Code
W0102160301 Fsh - rt & poc
Device Class
Class B
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000002170
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Assure Tech. (Hangzhou) Co., Ltd.

See all devices from Assure Tech. (Hangzhou) Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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