Skip to content

Unilatex

by Eurolatex Sdn. Bhd. 9 variants

Ref REF 3008Model Plain

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955410035270PLAINWN Basic UDI-DI 09551024780559UDI-DIDate26 Aug 2022RegisteredStatusActive

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  • Withdrawn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
Model / Reference
Plain, REF 3008
Primary DI / UDI-DI
09551024780559
Basic UDI-DI
955410035270PLAINWN
Direct Marketing DI
09551024780559
EMDN Code
U110101 Condoms
Device Class
Class IIb
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
MY-MF-000003748
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Eurolatex Sdn. Bhd.

See all devices from Eurolatex Sdn. Bhd. →

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