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Dilapan-S

by MEDICEM Technology s.r.o. EUDAMED510(k)GUDID

Active European Union and United States

Ref DS355, DS455, DS465Model Dilapan-S

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number085952317DS01C3 Basic UDI-DIDate13 Sep 2022RegisteredStatusActive
European UnionCE/MDR EUDAMED Number085952317DS01C3 Basic UDI-DIDate13 Sep 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08595231700284 UDI-DIDate1 May 2016ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK143447 Date17 Apr 2015IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Hygroscopic cervical dilator
Model / Ref / Catalog
Dilapan-S, DS355, DS465, DS455, 3x55 mm, 4x65 mm, 4x55 mm
Primary DI / UDI-DI
08595231700284, 08595231700260, 08595231700277, 08595231703551, 08595231704657, 08595231704558
Basic UDI-DI
085952317DS01C3, B-08595231700284, B-08595231700277, B-08595231700260
Direct Marketing DI
08595231700284
08595231700260
08595231700277
510(k) Number
FDA Product Code
PKN, LOB
EMDN Code
U99 Devices for urogenital system - other
GMDN Term
Hygroscopic cervical dilator
Device Class
Class IIa EUDAMED
Class II GUDID
Class III GUDID
Regulation Number
884.4260
Market of Registration
Czechia
Commercial Distribution
In Commercial Distribution
Not in Commercial Distribution
Size
Outer Diameter — 3 Millimeter
Length — 55 Millimeter
Outer Diameter — 4 Millimeter
Length — 65 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
Class III

Manufacturer details

EUDAMED SRN
CZ-MF-000000928

Other devices from MEDICEM Technology s.r.o.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No