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OvAi Focus

by SynDiag s.r.l. Italy EUDAMED

Ref 08052590540000Model OvAi Focus vMM.mm

EMDN Z11040182

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805259054OvAi2025KE Basic UDI-DIDate16 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
OvAi Focus vMM.mm, 08052590540000
Primary DI / UDI-DI
08052590540000
Basic UDI-DI
805259054OvAi2025KE
Direct Marketing DI
08052590540000
EMDN Code
Z11040182 Ultrasound scanners - software accessories
Device Class
Class I
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000042169

From the manufacturer

Manufacturer's product page: OvAI Focus

Other devices from SynDiag s.r.l.

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 efc89fc0-a634-449c-a957-305405878073 61 fields · synced 25 Oct 2026