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Skyn Elite King Size

by Suretex Limited Thailand EUDAMED

Ref 200509Model POLYISOPRENE CONDOMS lubricated with non medicinal lubricant

EMDN U110101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5011831PIcondom-NMLubC5 Basic UDI-DIDate22 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
POLYISOPRENE CONDOMS lubricated with non medicinal lubricant, 200509
Primary DI / UDI-DI
08859798103286
Basic UDI-DI
5011831PIcondom-NMLubC5
Direct Marketing DI
03532281606505
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
France

Manufacturer details

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

Other devices from Suretex Limited

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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 5f54253c-6534-4033-ba7f-a82cfb4e5d50 61 fields · synced 23 Oct 2026