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Follicle Stimulating Hormone (FSH) Rapid Quantitative Test

by Xenta Biomedical Science Co., Ltd. EUDAMED

Active European Union

Ref XRDL033A105OS

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975278860851 Basic UDI-DIDate8 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Follicle Stimulating Hormone (FSH) Rapid Quantitative Test
Model / Reference
XRDL033A105OS
Primary DI / UDI-DI
06975278860851
Basic UDI-DI
B-06975278860851
EMDN Code
W0102050104 Follicle stimulating hormone
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000057746
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Xenta Biomedical Science Co., Ltd.

See all devices from Xenta Biomedical Science Co., Ltd. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Near-Patient Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No