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CapSureFix Novus MRI™ SureScan™

by Medtronic, Inc. United States EUDAMED

Ref 407685 EMDN J0190010102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-00643169708280 Basic UDI-DIDate6 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/AIMDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
CapSureFix Novus Lead
Model / Reference
407685
Primary DI / UDI-DI
00643169708280, 00643169708341
Basic UDI-DI
B-00643169708280, B-00643169708341
EMDN Code
J0190010102 Endocardial atrial and ventricular leads, bipolar (with active or passive fixation)
Device Class
Class AIMDD
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000019977
Authorised representative
Medtronic B.V. NL-AR-000006050

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • Incorporates Medicinal Product
Other properties (10)
  • 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

Sources (2)

  • EUDAMED 58d5c83c-e3fd-4798-b9a1-c7e1fda7ae57 61 fields · synced 22 Oct 2026
  • EUDAMED 00643169708341|B-00643169708341 61 fields · synced 23 Oct 2026