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Sagami Original 002 L12 Extra Lubricated

by Sagami Manufacturers Sdn. Bhd. Malaysia EUDAMED

Ref UES053 EMDN U110101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04974234814442 Basic UDI-DIDate31 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Polyurethane condom
Model / Reference
UES053
Primary DI / UDI-DI
04974234814442
Basic UDI-DI
B-04974234814442
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 a6d4cf1d-e04e-4215-800f-113e15bce578 61 fields · synced 24 Oct 2026