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by Sagami Manufacturers Sdn. Bhd. Malaysia EUDAMED

Ref 002

EMDN U110101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08411134141057 Basic UDI-DIDate29 Jul 2024RegisteredStatusActive

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 Condoms
Model / Reference
002
Primary DI / UDI-DI
08411134141057
Basic UDI-DI
B-08411134141057
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
Spain

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 43350ae4-a059-4c2f-b480-e7cf559ff2fa 61 fields · synced 22 Oct 2026