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Amulet™

by Abbott Medical Ireland EUDAMED

Ref AMULET360-028 EMDN P070404

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5414734LAS0052HJ Basic UDI-DIDate13 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 842924 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    5 Aug 2026
    Expires
    4 Aug 2031

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Amulet 360 Left Atrial Appendage Occluder
Model / Reference
AMULET360-028
Primary DI / UDI-DI
05415067055439
Basic UDI-DI
5414734LAS0052HJ
EMDN Code
P070404 Left atrial appendage occluders
Device Class
Class III
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000016948
Authorised representative
Abbott Medical BE-AR-000008744

Other devices from Abbott Medical

See all devices from Abbott Medical →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • CMR Substance
Other properties (10)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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 05415067055439|5414734LAS0052HJ 61 fields · synced 25 Oct 2026