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Control Hydrafeel BX10

by Suretex Limited Thailand EUDAMED

Ref 301039Model NRL condoms non medicated lubricant

EMDN U110101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5011831NRLcondom-NMLubY2 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
NRL condoms non medicated lubricant, 301039
Primary DI / UDI-DI
08859798106911
Basic UDI-DI
5011831NRLcondom-NMLubY2
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
Spain

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 14f2185b-0df3-4eb0-81a1-4ca94afcfe3a 61 fields · synced 23 Oct 2026