Skip to content

Modul Predikce ovulace pro NIS IKIS

by Medical Systems a.s. Czechia EUDAMED

Ref IKIS25M12MCGNF01 EMDN Z12080292

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859423295ModulOvulace33 Basic UDI-DIDate14 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Modul Predikce ovulace pro NIS IKIS
Model / Reference
IKIS25M12MCGNF01
Primary DI / UDI-DI
08594232950001
Basic UDI-DI
859423295ModulOvulace33
Direct Marketing DI
08594232950001
EMDN Code
Z12080292 Gynaecology and fertility treatment instruments - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000051480

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED acf89abe-a842-4b55-8fe5-dd684b14f8d8 61 fields · synced 25 Oct 2026