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FC2 Female Condom

by The Female Health Company (UK) Plc United Kingdom EUDAMED

Ref 040822

EMDN U110203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5022213000009HC Basic UDI-DIDate13 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
FC2 Female Condom
Model / Reference
040822
Primary DI / UDI-DI
05022213000122
Basic UDI-DI
5022213000009HC
EMDN Code
U110203 Female condoms
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
GB-MF-000029355
Authorised representative
Advena Limited MT-AR-000000234

Other devices from The Female Health Company (UK) Plc

See all devices from The Female Health Company (UK) Plc →

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 e6ea3434-0199-482e-bc93-e857748f78cb 61 fields · synced 23 Oct 2026