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Eros Don Juan

by Dongkuk Vietnam Co., Ltd. EUDAMED

Active European Union

Ref 01Model Natural rubber latex male condoms (non-medicated)

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8938503458DKVNTF01LH Basic UDI-DIDate8 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • KR25/00000120 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    23 Oct 2025
    Expires
    23 Oct 2030
    Reason
    Change approved

Specification

EUDAMED

Model / Reference
Natural rubber latex male condoms (non-medicated), 01
Primary DI / UDI-DI
08938503458030
Basic UDI-DI
8938503458DKVNTF01LH
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
VN-MF-000043647
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Dongkuk Vietnam Co., Ltd.

Properties

  • 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