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Latitude™

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

Ref 7246

Expiring European Union

CE MDR

Valid until

23 Aug 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 749618 Date18 Sep 2026IssuedStatusExpiring expires 23 Aug 2027

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 749618 Expiring Supplemented Expires in 298 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    18 Sep 2026
    Expires
    23 Aug 2027
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
LATITUDE Clarity Devices Services software for ICM
Model / Reference
7246
Primary DI / UDI-DI
00802526613883
Basic UDI-DI
01915060000000000000223MN
EMDN Code
Z12050782 Instruments for cardiological polygraphy - software accessories
Device Class
Class III
Special Device Type
Software
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