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Smile - Classic & Smile

by Pleasure Latex Products Sdn. Bhd. Malaysia EUDAMED

Ref 179 EMDN U110101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-19555012422701 Basic UDI-DIDate14 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Natural Rubber Latex Male Condom
Model / Reference
179
Primary DI / UDI-DI
19555012422701
Basic UDI-DI
B-19555012422701
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
France

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 (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 9feb2f68-5d91-43dc-ac83-b6a2a1db8b8a 61 fields · synced 25 Oct 2026