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Capsurefix® MRI

by Medtronic, Inc.

Ref 5086MRI58C

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE AIMDD, withdrawn

Ended

Withdrawn

Date not published (CE AIMDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-00613994206367 Basic UDI-DI 00613994206367UDI-DIDate22 Jul 2026RegisteredStatusWithdrawn No longer placed on the EU market

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/AIMDD Withdrawn

Specification

EUDAMED

Device Name
5086MRI CapSure Fix MRI Lead
Model / Reference
5086MRI58C
Primary DI / UDI-DI
00613994206367
Basic UDI-DI
B-00613994206367
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