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POLARx™

by Boston Scientific Corporation United States EUDAMED

Ref M004CRBS2010

EMDN C020302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number01915060000000000000216MR Basic UDI-DIDate24 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 097167 0040 Cancelled

    Technical documentation EU MDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    23 Mar 2023
    Expires
    22 Mar 2028
    Reason
    Other

Specification

EUDAMED · synced 25 Oct 2026

Device Name
POLARx Cryoablation Catheter
Model / Reference
M004CRBS2010
Primary DI / UDI-DI
08714729992578
Basic UDI-DI
01915060000000000000216MR
EMDN Code
C020302 Arrhythmogenic foci cryoenergy ablation catheters
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000004702
Authorised representative
Boston Scientific Limited IE-AR-000003840

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (1)

  • EUDAMED 08714729992578|01915060000000000000216MR 61 fields · synced 25 Oct 2026