Skip to content

Protex performance

by Sagami Rubber Industries Co., Ltd. Japan EUDAMED

Ref ES5612 EMDN U110101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03760043360000 Basic UDI-DIDate28 May 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Natural rubber latex condom
Model / Reference
ES5612
Primary DI / UDI-DI
03760043360000
Basic UDI-DI
B-03760043360000
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
JP-MF-000040149
Authorised representative
Sagami Europe SAS FR-AR-000038926

Other devices from Sagami Rubber Industries Co., Ltd.

See all devices from Sagami Rubber Industries Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Contains Latex
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED da29a5fd-c3bc-460e-9865-6a815aca85c2 61 fields · synced 22 Oct 2026