Skip to content

Dilasoft

by MEDICEM Technology s.r.o. EUDAMED

Active European Union

Ref DF455Model Dilasoft

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number085952317DF01A2 Basic UDI-DIDate13 Sep 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Dilasoft, DF455
Primary DI / UDI-DI
08595231703322
Basic UDI-DI
085952317DF01A2, B-08595231703322
Direct Marketing DI
08595231703322
EMDN Code
U99 Devices for urogenital system - other
Device Class
Class IIa
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000000928

Other devices from MEDICEM Technology s.r.o.

  • Dilasoft

    Class IIa

  • Dilapan

    Class III

  • Dilapan-S

    Class IIa

  • Dilasoft

    Class IIa

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: 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