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LUX-Dx II™

by Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation United States EUDAMED

Ref M302

EMDN J010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number01915060000000000000219MX Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 749618 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    18 Sep 2026
    Expires
    23 Aug 2027
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Insertable cardiac monitor (ICM) sensor
Model / Reference
M302
Primary DI / UDI-DI
00802526623608
Basic UDI-DI
01915060000000000000219MX
EMDN Code
J010201 Implantable diagnostic arrhythmias recording cardiac devices
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

See all devices from Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 00802526623608|01915060000000000000219MX 61 fields · synced 24 Oct 2026