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FC2 Female Condom

by The Female Health Company (UK) Plc 16 variants

Ref FC2 Female Condom (Generic) CE Pack of 500

Active European Union

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5022213000009HC Basic UDI-DI 15022213000006UDI-DIDate13 May 2024RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
FC2 Female Condom
Model / Reference
FC2 Female Condom (Generic) CE Pack of 500
Primary DI / UDI-DI
15022213000006
Basic UDI-DI
5022213000009HC
EMDN Code
U110203 Female condoms
Device Class
Class IIb
EU 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

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