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Acuity™

by Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation 20 variants

Ref 8112

Active European Union

CE MDR

Valid until

1 Apr 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number01915060000000000000391NC Basic UDI-DI 00802526626722UDI-DIDate16 Sep 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 790667 Active

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    2 Apr 2024
    Expires
    1 Apr 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
ACUITY™ Pro Guide Catheters
Model / Reference
8112
Primary DI / UDI-DI
00802526626722
Basic UDI-DI
01915060000000000000391NC
EMDN Code
C0104010202 Cardiac angiography guide catheters
Device Class
Class III
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000010993
Authorised representative
Guidant Europe NV/SA; Boston Scientific BE-AR-000008410

Other devices from Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation

  • myLUX™

    Class III

  • Acuity™

    Class III

  • Momentum™

    Class III

  • Latitude™

    Class III

  • Dynagen™

    Class III

  • Resonate™

    Class III

See all devices from Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation →

Properties

  • Sterile
  • CMR Substance

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No