Skip to content

Protex Standard Plus

by Sagami Rubber Industries Co., Ltd. Japan EUDAMED

Ref ES5376 EMDN U110101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number4974234NRCDM013K Basic UDI-DIDate14 Feb 2025RegisteredStatusActive
European UnionCE/MDR Number4974234NRCDM013K Basic UDI-DIDate14 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Natural rubber latex condom
Model / Reference
ES5376
Primary DI / UDI-DI
03760043367191
Basic UDI-DI
4974234NRCDM013K, B-03760043367191
Direct Marketing DI
03760043367191
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 (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 (2)

  • EUDAMED 0ac92087-5b3f-4e92-8c07-f680a8dd3fd8 61 fields · synced 22 Oct 2026
  • EUDAMED 03760043367191|B-03760043367191 61 fields · synced 5 Oct 2026