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ACIST Pro Single Transducer Cable

by ACIST Medical Systems, Inc.

Ref 019608Model ACIST Pro, Accessory_Hemodynamic Cable

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08417161000016G2 Basic UDI-DI Date29 Oct 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
ACIST Pro Single Transducer Cable
Single Transducer Cable
Device Name
ACIST Pro Accessories
Hemodynamic Cable
Model / Reference
ACIST Pro, 019608, Accessory_Hemodynamic Cable
Primary DI / UDI-DI
30841716103415, 10841716103411
Basic UDI-DI
08417161000016G2, 08417161000019G8
EMDN Code
Z11039080, Z11039099
Device Class
Class I
EU 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

Other devices from ACIST Medical Systems, Inc.

See all devices from ACIST Medical Systems, Inc. →

Properties

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