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Protex Classic Green

by Sagami Rubber Industries Co., Ltd. Japan EUDAMED

Ref ES5465, ES5466, ES5468 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  • Withdrawn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
ES5465, ES5466, ES5468
Primary DI / UDI-DI
03760043365364, 03760043362752, 03760043365999
Basic UDI-DI
4974234NRCDM013K, B-03760043362752, B-03760043365364, B-03760043365999
Direct Marketing DI
03760043365364
03760043362752
03760043365999
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 (6)

  • EUDAMED 3dca3a1e-f423-4559-a60c-c9eb5c296769 61 fields · synced 22 Oct 2026
  • EUDAMED 03760043362752|4974234NRCDM013K 61 fields · synced 18 May 2026
  • EUDAMED 03760043365999|4974234NRCDM013K 61 fields · synced 19 May 2026
  • EUDAMED 03760043362752|B-03760043362752 61 fields · synced 11 Jul 2026
  • EUDAMED 03760043365364|B-03760043365364 61 fields · synced 13 Jul 2026
  • EUDAMED 03760043365999|B-03760043365999 61 fields · synced 29 Jul 2026