Skip to content

CVi Ground Cable

by ACIST Medical Systems, Inc. United States EUDAMED

Ref 015753Model ACIST CVi Contrast Delivery System Accessories

EMDN Z11049080

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08417161000003FR Basic UDI-DIDate19 Mar 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
ACIST CVi Contrast Delivery System Accessories, 015753
Primary DI / UDI-DI
30841716101626
Basic UDI-DI
08417161000003FR
EMDN Code
Z11049080 Various ultrasound instruments - hardware accessories
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000010784
Authorised representative
ACIST Europe BV NL-AR-000002151

Other devices from ACIST Medical Systems, Inc.

See all devices from ACIST Medical Systems, Inc. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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 6582e8c8-bb1f-4944-b38e-d055f08bca1f 61 fields · synced 22 Oct 2026