Skip to content

Fair Squared Original

by Innolatex (Thailand) Limited EUDAMED

Active European Union

Ref P54S FXN4, 4719646

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-04260365853109 Basic UDI-DIDate9 Nov 2023RegisteredStatusActive
European UnionCE/MDD NumberB-04260365853109 Basic UDI-DIDate9 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Non-Medicated Natural Rubber Latex Male Condom
Non-sterile, Non-medicated Natural Rubber Latex Male Condoms
Model / Reference
P54S FXN4, 4719646
Primary DI / UDI-DI
04260365853109, 04260365853093
Basic UDI-DI
B-04260365853109, B-04260365853093, 9556564-NMCM-U4
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
Germany
Austria

Manufacturer details

EUDAMED SRN
TH-MF-000001249
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Innolatex (Thailand) Limited

See all devices from Innolatex (Thailand) Limited →

Properties

  • 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