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RXi System dPR

by ACIST Medical Systems, Inc. United States EUDAMED

Ref 016616

EMDN C010403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10841716103572 Basic UDI-DIDate4 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Rapid Exchange (RXi) System, dPR
Model / Reference
016616
Primary DI / UDI-DI
10841716103572
Basic UDI-DI
B-10841716103572
EMDN Code
C010403 Fractional flow reserve (ffr) measurement devices
Device Class
Class IIa
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
  • Reusable
  • Measuring Function
Other properties (9)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 0b7b7285-4371-49cc-a584-2c12e844daf5 61 fields · synced 22 Oct 2026