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MYOovunelle

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

Active European Union

Ref MYOovunelle

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberEPT 0477.MDR.22/5003.3 Date29 Sep 2025IssuedStatusActive expires 3 Aug 2027

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.22/5003.3 Reissued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    29 Sep 2025
    Expires
    3 Aug 2027

Specification

EUDAMED

Device Name
XYMINAL Ovuli vaginali
Model / Reference
MYOovunelle
Primary DI / UDI-DI
08058481250508
Basic UDI-DI
805848125XyminalBQ
EMDN Code
U0899 Gynaecological devices - other
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000023734

Other devices from LO.LI. PHARMA S.r.l.

See all devices from LO.LI. PHARMA S.r.l. →

Properties

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