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Denniston Dilators

by WomanCare Global, LLC United States EUDAMED

Ref DD5-S

EMDN Z12080299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0853615006DILATORSPC Basic UDI-DIDate25 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
DD5-S
Primary DI / UDI-DI
00853615006376
Basic UDI-DI
0853615006DILATORSPC
EMDN Code
Z12080299 Gynaecology and fertility treatment instruments - other
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000042625
Authorised representative
Donawa Lifescience Consulting Srl IT-AR-000007785

Other devices from WomanCare Global, LLC

See all devices from WomanCare Global, LLC →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 228eda88-969a-481b-a8a7-548673ab1584 61 fields · synced 22 Oct 2026