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Biguanelle Pessaries

by LO.LI. PHARMA S.r.l. 2 variants

Ref BIGUANELLE PESSARIESModel MONOGIN OVULI VAGINALI

Expiring European Union

CE MDR

Valid until

3 Aug 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Eurofins Product Testing Italy S.r.l.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberEPT 0477.MDR.23/5059.5 Date25 Mar 2026IssuedStatusExpiring EUDAMED: not on the EU market expires 3 Aug 2027

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.23/5059.5 Expiring Reissued Expires in 275 days

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    25 Mar 2026
    Expires
    3 Aug 2027

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Monogin Ovuli Vaginali
Model / Reference
MONOGIN OVULI VAGINALI, BIGUANELLE PESSARIES
Primary DI / UDI-DI
08058481250287, 08058481250904
Basic UDI-DI
805848125MONOGINovuliNL
EMDN Code
U0899 Gynaecological devices - other
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
IT-MF-000023734

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

  • SANTES Gel

    Class IIb

  • Pervistop Ovuli

    Class IIb

  • SANTES® hüvelyikúp

    Class IIb

  • Eumastos Gel

    Class IIa

  • Premeno

    Class IIb

  • IAGYNEL® Ovuli Vaginali

    Class IIb

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