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CapSure Sense MRI™ SureScan®

by Medtronic, Inc.

Ref 457453

Active European Union

CE AIMDD

Valid until

Not listed

EUDAMED holds no validity date

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-00643169410923 Basic UDI-DI Date12 Aug 2026RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
4574 CapSure Sense Lead
Model / Reference
457453
Primary DI / UDI-DI
00643169410923, 00643169410893, 00763000079413, 00763000079390, 00643169044241, 00643169044258
Basic UDI-DI
B-00643169410923, B-00643169410893, B-00763000079413, B-00763000079390, B-00643169044241, B-00643169044258
EMDN Code
J0190010102 Endocardial atrial and ventricular leads, bipolar (with active or passive fixation)
Device Class
Class AIMDD
EU 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