Skip to content

Latitude™

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

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 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  • Withdrawn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 3 May 2022
  • Belgium since 3 May 2022
  • Bulgaria since 3 May 2022
  • Croatia since 3 May 2022
  • Cyprus since 3 May 2022
  • Czechia since 3 May 2022
  • Denmark since 3 May 2022
  • Estonia since 3 May 2022
  • Finland since 3 May 2022
  • France since 3 May 2022
  • Germany since 3 May 2022
  • Greece since 3 May 2022
  • Hungary since 3 May 2022
  • Iceland since 3 May 2022
  • Ireland since 3 May 2022
  • Italy since 3 May 2022
  • Latvia since 3 May 2022
  • Liechtenstein since 3 May 2022
  • Lithuania since 3 May 2022
  • Luxembourg since 3 May 2022
  • Malta since 3 May 2022
  • Netherlands since 3 May 2022
  • Northern Ireland since 3 May 2022
  • Norway since 3 May 2022
  • Poland since 3 May 2022
  • Portugal since 3 May 2022
  • Romania since 3 May 2022
  • Slovakia since 3 May 2022
  • Slovenia since 3 May 2022
  • Spain since 3 May 2022
  • Sweden since 3 May 2022
  • Türkiye since 3 May 2022

Last checked 28 Oct 2026.

Specification

EUDAMED

Device Name
LATITUDE Communicator
Primary DI / UDI-DI
00802526585678
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