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ACIST CVi AngioTouch® AT X65 HAND CONTROLLER KIT

by ACIST Medical Systems, Inc. United States EUDAMED

Ref 016794Model 014612 EMDN Z11039085

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08417161000002FP Basic UDI-DIDate13 Dec 2024RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Device Name
A2000 Syringe Kit
Model / Reference
014612, 016794
Primary DI / UDI-DI
10841716103206
Basic UDI-DI
08417161000002FP
EMDN Code
Z11039085 Various radiodiagnostic and interventional instruments - consumables
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

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

From the manufacturer

Manufacturer's product page: ACIST CVi®

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
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 080c9d79-b993-4c1c-8e9f-25c41b163bdb 61 fields · synced 22 Oct 2026