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Sagami Original 002 XL12

by Sagami Manufacturers Sdn. Bhd. Malaysia EUDAMED

Ref UES045

EMDN U110101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04974234813926 Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Polyurethane condom
Model / Reference
UES045
Primary DI / UDI-DI
04974234813926
Basic UDI-DI
B-04974234813926
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
Czechia

Manufacturer details

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

Other devices from Sagami Manufacturers Sdn. Bhd.

See all devices from Sagami Manufacturers Sdn. Bhd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 71ffcf1f-1571-48f0-a279-2beeb419ee01 61 fields · synced 22 Oct 2026