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Dash™

by Merit Medical Systems, Inc. United States EUDAMED

Ref SIH9F23-02Model K15 & K21

EMDN V0599

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0884450BUDI659QN Basic UDI-DIDate9 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
K15 & K21 Vascular catheter introduction kit
Model / Reference
K15 & K21, SIH9F23-02
Primary DI / UDI-DI
00884450454541
Basic UDI-DI
0884450BUDI659QN
EMDN Code
V0599 Clinical procedures kits not included in other classes - other
Device Class
Class IIa
Medical Purpose
To facilitate the placement of catheters through the skin into a vein or artery.

Manufacturer details

EUDAMED SRN
US-PR-000008345

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 00884450454541|0884450BUDI659QN 61 fields · synced 25 Oct 2026