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Fsh Irma Kit

by IMMUNOTECH s.r.o. 2 variants

Ref IM3301Model Immunoassay IM2125, IM3301

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number150995905FSHIRMATA Basic UDI-DI 15099590218904UDI-DIDate12 Jul 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
Immunoassay IM2125, IM3301
Primary DI / UDI-DI
15099590218904
Basic UDI-DI
150995905FSHIRMATA
EMDN Code
W0102050104 Follicle stimulating hormone
Device Class
Class B
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000001761

Other devices from IMMUNOTECH s.r.o.

See all devices from IMMUNOTECH s.r.o. →

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