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Serena™ Quad CRT-P MRI SureScan™

by Medtronic, Inc. EUDAMED

Active European Union

Ref W4TR05

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-00763000108854 Basic UDI-DIDate18 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  • Withdrawn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
Percepta, Serena, Solara CRT-P
Model / Reference
W4TR05
Primary DI / UDI-DI
00763000108854
Basic UDI-DI
B-00763000108854
EMDN Code
J01010401 Implantable triple chamber pacemakers for cardiac resynchronization (tr)
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
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