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Fiesta Dotted

by Innolatex Sdn. Bhd. Malaysia EUDAMED

Ref CS-001-810

EMDN U110101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955516330-NMCM-6F Basic UDI-DIDate28 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Non-sterile Non-medicated Natural Rubber Latex Male Condoms
Model / Reference
CS-001-810
Primary DI / UDI-DI
09555163309435
Basic UDI-DI
955516330-NMCM-6F
EMDN Code
U110101 Condoms
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
MY-MF-000001246
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Innolatex Sdn. Bhd.

See all devices from Innolatex Sdn. Bhd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED d5a6040a-82ec-4bfb-be1c-6ecbaac21412 61 fields · synced 22 Oct 2026