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Latitude™

by Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation 15 variants

Ref 6290

Expiring European Union

CE MDR

Valid until

27 Apr 2027

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 742788 Date18 Jun 2026IssuedStatusExpiring expires 27 Apr 2027

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 742788 Expiring Supplemented Expires in 180 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    18 Jun 2026
    Expires
    27 Apr 2027
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

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 Sep 2024
  • Belgium since 22 Sep 2024
  • Bulgaria since 22 Sep 2024
  • Croatia since 22 Sep 2024
  • Cyprus since 22 Sep 2024
  • Czechia since 22 Sep 2024
  • Denmark since 22 Sep 2024
  • Estonia since 22 Sep 2024
  • Finland since 22 Sep 2024
  • France since 22 Sep 2024
  • Germany since 22 Sep 2024
  • Greece since 22 Sep 2024
  • Hungary since 22 Sep 2024
  • Iceland since 22 Sep 2024
  • Ireland since 22 Sep 2024
  • Italy since 22 Sep 2024
  • Latvia since 22 Sep 2024
  • Liechtenstein since 22 Sep 2024
  • Lithuania since 22 Sep 2024
  • Luxembourg since 22 Sep 2024
  • Malta since 22 Sep 2024
  • Netherlands since 22 Sep 2024
  • Northern Ireland since 22 Sep 2024
  • Norway since 22 Sep 2024
  • Poland since 22 Sep 2024
  • Portugal since 22 Sep 2024
  • Romania since 22 Sep 2024
  • Slovakia since 22 Sep 2024
  • Slovenia since 22 Sep 2024
  • Spain since 22 Sep 2024
  • Sweden since 22 Sep 2024
  • Türkiye since 22 Sep 2024

Last checked 29 Oct 2026.

Specification

EUDAMED

Device Name
LATITUDE Communicator
Model / Reference
6290
Primary DI / UDI-DI
00802526625756, 00802526617812, 00802526625770
Basic UDI-DI
01915060000000000000148MZ
EMDN Code
J010702 Pacemaker and implantable defibrillator remote monitoring systems
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

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

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