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O.K. Okey Zero Tenn Prezervati̇f 8'Lİ

by Suretex Limited Thailand EUDAMED

Ref 280002Model POLYISOPRENE CONDOMS lubricated with non medicinal lubricant EMDN U110101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5011831PIcondom-NMLubC5 Basic UDI-DIDate22 Aug 2025RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
POLYISOPRENE CONDOMS lubricated with non medicinal lubricant, 280002
Primary DI / UDI-DI
08850956034527
Basic UDI-DI
5011831PIcondom-NMLubC5
EMDN Code
U110101 Condoms
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
TH-MF-000001364
Authorised representative
SXWell Belgium BE-AR-000001272

Other devices from Suretex Limited

See all devices from Suretex Limited →

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 08850956034527|5011831PICONDOM-NMLUBC5 61 fields · synced 24 Oct 2026