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Sprint Quattro Secure MRI™ SureScan™

by Medtronic, Inc. EUDAMED

Active European Union

Ref 694758

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-00643169690011 Basic UDI-DIDate29 Sep 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  • Withdrawn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

Device Name
Defibrillation Lead
Model / Reference
694758
Primary DI / UDI-DI
00643169690011
Basic UDI-DI
B-00643169690011
EMDN Code
J019001020102 Permanent cardiac defibrillator leads, double coil
Device Class
Class AIMDD
Market of Registration
Netherlands

Manufacturer details

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

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Properties

Show 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