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Pasante Extra

by Innolatex (Thailand) Limited EUDAMED

Withdrawn Not intended for the EU market

Ref R0307K-AL

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88586938-NMCM-V9 Basic UDI-DIDate4 Sep 2024RegisteredStatusWithdrawn 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  • Withdrawn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European Union — CE/MDR Withdrawn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

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 Condoms
Model / Reference
R0307K-AL
Primary DI / UDI-DI
05060493184521
Basic UDI-DI
88586938-NMCM-V9
EMDN Code
U110101 Condoms
Device Class
Class IIb

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