Skip to content

Mister Size 47

by Karex Industries Sdn. Bhd. EUDAMED

Active European Union

Ref P47S XUT, BULKMS47100, MS4703

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-04260605480010 Basic UDI-DIDate15 Jan 2024RegisteredStatusActive
European UnionCE/MDD NumberB-04260605480010 Basic UDI-DIDate15 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

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.

Specification

EUDAMED

Trade Name
Mister Size 47
Mister Size Size 47
Device Name
Non-sterile Non-medicated Natural Rubber Latex Male Condom
Non-sterile, Non-medicated Natural Rubber Latex Male Condoms
Model / Reference
P47S XUT, BULKMS47100, MS4703
Primary DI / UDI-DI
04260605480010, 04260605482281
Basic UDI-DI
B-04260605480010, 9556564-NMCM-U4
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
MY-MF-000001247
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Karex Industries Sdn. Bhd.

See all devices from Karex Industries 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