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Gynophilus

by Biose Industrie

Ref F1-19-01, F1-18-01

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-FR-MF-0000158804T Basic UDI-DI Date8 Nov 2021RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Trade Name
Gynophilus
Gynophilus Restore
Device Name
Gynophilus, vaginal capsule
Gynophilus LP Vaginal Tablet
Model / Reference
F1-19-01, F1-18-01
Primary DI / UDI-DI
D-FR-MF-0000158804T, D-FR-MF-000015880-00135
Basic UDI-DI
B-FR-MF-0000158804T, B-FR-MF-000015880-00135
EMDN Code
U0803 Vaginal devices in the form of solutions/creams/ova/tablets
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000015880

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No