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WINK Mega Condom

by Okamoto Rubber Products Co., Ltd.

Ref 12pcs

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4769100000000000000001565 Basic UDI-DI 08438001413055UDI-DIDate12 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Natural Rubber Latex Male Condom is for purpose of contraception and prevention of sexually transmitted infections.
Model / Reference
12pcs
Primary DI / UDI-DI
08438001413055
Basic UDI-DI
4769100000000000000001565
EMDN Code
U110101 Condoms
Device Class
Class IIb
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
TH-MF-000012368
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Okamoto Rubber Products Co., Ltd.

See all devices from Okamoto Rubber Products 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