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CapSureFix Novus MRI™ SureScan™

by Medtronic, Inc. EUDAMED

Active European Union

Ref 5076-52

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-00763000079444 Basic UDI-DIDate6 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/AIMDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
CapSureFix Novus Lead
5076 CapSureFix Novus Lead
Model / Reference
5076-52
Primary DI / UDI-DI
00763000079444, 00643169278943, 00643169278981, 00643169278844, 00643169633810, 00643169633872, 00643169577176, 00763000079499
Basic UDI-DI
B-00763000079444, B-00643169278943, B-00643169278981, B-00643169278844, B-00643169633810, B-00643169633872, B-00643169577176, B-00763000079499
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

  • 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