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Protex Extra Large

by Sagami Rubber Industries Co., Ltd. Japan EUDAMED

Ref ES6414

EMDN U110101

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Natural rubber latex condom
Model / Reference
ES6414
Primary DI / UDI-DI
03760043360659
Basic UDI-DI
4974234NRCDM013K
Direct Marketing DI
03760043360659
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 (1)

  • EUDAMED f9e59e33-9d14-4c64-9875-294dab0dd0b3 61 fields · synced 22 Oct 2026