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Advisa DR MRI™ SureScan™

by Medtronic, Inc. United States EUDAMED

Ref A3DR01

EMDN J01010302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-00643169582262 Basic UDI-DIDate13 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/AIMDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Advisa DR MRI
Model / Reference
A3DR01
Primary DI / UDI-DI
00643169582262
Basic UDI-DI
B-00643169582262
EMDN Code
J01010302 Implantable dual chamber pacemakers with sensor (dr)
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
Other properties (11)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 00643169582262|B-00643169582262 61 fields · synced 24 Oct 2026