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SKYN ELITE box of 10 condoms FR

by Suretex Limited Thailand EUDAMED

Ref 200357Model POLYISOPRENE CONDOMS lubricated with non medicinal lubricant

EMDN U110101

Regulatory status

as of 24 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 22 Oct 2026

Model / Reference
POLYISOPRENE CONDOMS lubricated with non medicinal lubricant, 200357
Primary DI / UDI-DI
08859798102319
Basic UDI-DI
5011831PIcondom-NMLubC5
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

See all devices from Suretex Limited →

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 682c8915-af42-4fb9-a1ff-91a7917e927d 61 fields · synced 22 Oct 2026