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ACIST Pro

by ACIST Medical Systems, Inc. United States EUDAMED

Ref 019312Model ACIST Pro System

EMDN Z11039080

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08417161000014FW Basic UDI-DIDate24 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
ACIST Pro Diagnostic System
Model / Reference
ACIST Pro System, 019312
Primary DI / UDI-DI
10841716103664
Basic UDI-DI
08417161000014FW
Direct Marketing DI
10841716103664
EMDN Code
Z11039080 Various radiodiagnostic and interventional instruments - hardware accessories
Device Class
Class IIb
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: Bracco and ACIST Medical Systems Announce U.S. FDA Clearance of ACIST Pro™ Diagnostic System: VIEW HERE

Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
  • Measuring Function
Other properties (11)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 12866f2f-df5a-4bc8-8f9c-b98ccf78dd5c 61 fields · synced 22 Oct 2026