Skip to content

Fiesta Classic

by Pleasure Latex Products Sdn. Bhd. Malaysia EUDAMED

Ref FC12

EMDN U110101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955501242LC0013W Basic UDI-DIDate27 Jul 2026RegisteredStatusActive

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
Natural Rubber Latex Male Condom
Model / Reference
FC12
Primary DI / UDI-DI
09555012423077
Basic UDI-DI
955501242LC0013W
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
MY-MF-000016199
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Pleasure Latex Products Sdn. Bhd.

See all devices from Pleasure Latex Products Sdn. Bhd. →

Properties & raw data

Show properties, registry sources and raw records
  • Contains Latex
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: 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 ca089b46-315d-45df-9369-a357c4cb58d4 61 fields · synced 23 Oct 2026