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Vigilant™

by Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation 16 variants

Ref G237

Active European Union

CE MDR

Valid until

20 Jul 2031

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 735821 Date15 Jul 2026IssuedStatusActive expires 20 Jul 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 735821 Active Reissued

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Jul 2026
    Expires
    20 Jul 2031
    Valid from
    20 Jul 2026

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

EU market availability

Made available in 32 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 22 Jul 2021
  • Belgium since 22 Jul 2021
  • Bulgaria since 22 Jul 2021
  • Croatia since 22 Jul 2021
  • Cyprus since 22 Jul 2021
  • Czechia since 22 Jul 2021
  • Denmark since 22 Jul 2021
  • Estonia since 22 Jul 2021
  • Finland since 22 Jul 2021
  • France since 22 Jul 2021
  • Germany since 22 Jul 2021
  • Greece since 22 Jul 2021
  • Hungary since 22 Jul 2021
  • Iceland since 22 Jul 2021
  • Ireland since 22 Jul 2021
  • Italy since 22 Jul 2021
  • Latvia since 22 Jul 2021
  • Liechtenstein since 22 Jul 2021
  • Lithuania since 22 Jul 2021
  • Luxembourg since 22 Jul 2021
  • Malta since 22 Jul 2021
  • Netherlands since 22 Jul 2021
  • Northern Ireland since 22 Jul 2021
  • Norway since 22 Jul 2021
  • Poland since 22 Jul 2021
  • Portugal since 22 Jul 2021
  • Romania since 22 Jul 2021
  • Slovakia since 22 Jul 2021
  • Slovenia since 22 Jul 2021
  • Spain since 22 Jul 2021
  • Sweden since 22 Jul 2021
  • Türkiye since 22 Jul 2021

Last checked 28 Oct 2026.

Specification

EUDAMED

Device Name
Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Model / Reference
G237
Primary DI / UDI-DI
00802526589270, 00802526595288
Basic UDI-DI
01915060000000000000083MW
EMDN Code
J01050301 Implantable triple chamber defibrillators, with sensors
Device Class
Class III
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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See all devices from Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation →

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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