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Supportrak®

by Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation 2 variants

Ref 6668

Active European Union

CE MDR

Valid until

13 Feb 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 Number01915060000000000000389NR Basic UDI-DI 00802526524868UDI-DIDate6 Nov 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 790669 Active

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    14 Feb 2024
    Expires
    13 Feb 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
SUPPORTRAK™ Finishing Wire
Model / Reference
6668
Primary DI / UDI-DI
00802526524868
Basic UDI-DI
01915060000000000000389NR
EMDN Code
C04010201 Coronary artery therapeutic guidewires, hydrophilic
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

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  • Latitude™

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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