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Protex Classic Plus Fin

by Sagami Rubber Industries Co., Ltd. Japan EUDAMED

Ref ES5619

EMDN U110101

Regulatory status

as of 24 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
  • 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
ES5619
Primary DI / UDI-DI
03760043367030
Basic UDI-DI
4974234NRCDM013K, B-03760043367030
Direct Marketing DI
03760043367030
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 4779026f-0751-446d-b3b7-8a410fc962f8 61 fields · synced 22 Oct 2026
  • EUDAMED 67ce6b03-f71a-4727-a423-786aaa167e42 61 fields · synced 6 Oct 2026