Skip to content

OSIS Ovary

by Fertoolity SL Spain EUDAMED

Ref v2.0

EMDN Z11049092

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8437024165OSIS7J Basic UDI-DIDate26 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
OSIS (Online Ultrasound Image Segmentation System) Ovary
Model / Reference
v2.0
Primary DI / UDI-DI
08437024165026
Basic UDI-DI
8437024165OSIS7J
Direct Marketing DI
08437024165026
EMDN Code
Z11049092 Various ultrasound instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000034274

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED c655e6a0-6d55-4173-bf04-6e9a391d8736 61 fields · synced 22 Oct 2026