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Mister Size Size 57

by Karex Industries Sdn. Bhd. EUDAMED

Active European Union

Ref MS5703, P57S 57J XUT

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number9556564-NMCM-U4 Basic UDI-DIDate19 Dec 2022RegisteredStatusActive
European UnionCE/MDR Number9556564-NMCM-U4 Basic UDI-DIDate19 Dec 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Trade Name
Mister Size Size 57
Mister Size 57
Device Name
Non-sterile, Non-medicated Natural Rubber Latex Male Condoms
Non-sterile Non-medicated Natural Rubber Latex Male Condom
Model / Reference
MS5703, P57S 57J XUT
Primary DI / UDI-DI
04260605480102
Basic UDI-DI
9556564-NMCM-U4, B-04260605480102
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
Denmark
Germany

Manufacturer details

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

Other devices from Karex Industries Sdn. Bhd.

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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