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Protex ORG002-12

by Sagami Manufacturers Sdn. Bhd. Malaysia EUDAMED

Ref UES308

EMDN U110101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number4974234PUCDM015U Basic UDI-DIDate30 Jan 2024RegisteredStatusActive
European UnionCE/MDR Number4974234PUCDM015U Basic UDI-DIDate30 Jan 2024RegisteredStatusActive

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

Trade Name
Protex ORG002-12
Protex Original 002-12
Device Name
Polyurethane Condom
Model / Reference
UES308
Primary DI / UDI-DI
03760043362615
Basic UDI-DI
4974234PUCDM015U, B-03760043362615
Direct Marketing DI
03760043362615
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
MY-MF-000039689
Authorised representative
Sagami Europe SAS FR-AR-000038926

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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 fa75db21-99e9-4540-9370-478258cd6a44 61 fields · synced 22 Oct 2026
  • EUDAMED 03760043362615|B-03760043362615 61 fields · synced 11 Jun 2026