Skip to content

Effectra™ SR MRI SureScan™

by Medtronic, Inc. United States EUDAMED

Ref BRD1SR2

EMDN J01010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0763000B000324685 Basic UDI-DIDate16 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Vitalis Impantable Pulse Generator
Model / Reference
BRD1SR2
Primary DI / UDI-DI
00763000991739
Basic UDI-DI
0763000B000324685
EMDN Code
J01010102 Implantable single chamber pacemakers with sensor (sr)
Device Class
Class III
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 00763000991739|0763000B000324685 61 fields · synced 24 Oct 2026