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IAGYNEL® Ovuli Vaginali

by LO.LI. PHARMA S.r.l. Italy EUDAMED

Ref IAGYNEL® Ovuli VaginaliModel Ovulo Vaginale / Vaginal Capsul

EMDN U0899

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberEPT 0477.MDR.22/4914.2 Date24 May 2024IssuedStatusActive expires 3 Aug 2027

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.22/4914.2 Reissued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    24 May 2024
    Expires
    3 Aug 2027

Specification

EUDAMED · synced 22 Oct 2026

Device Name
SANTES Ovuli
Model / Reference
Ovulo Vaginale / Vaginal Capsul, IAGYNEL® Ovuli Vaginali
Primary DI / UDI-DI
08058481250768, 08058481250744
Basic UDI-DI
805848125SantesOvuliWF
EMDN Code
U0899 Gynaecological devices - other
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000023734

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 (2)

  • EUDAMED f5bf51aa-15e7-4946-b5c0-812e84085be3 61 fields · synced 22 Oct 2026
  • EUDAMED 70328cd4-31fb-4b02-98f4-a43a40993fe3 61 fields · synced 18 May 2026