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HeartR

by LifeTech Scientific (Europe) B.V. Netherlands EUDAMED

Ref LEFS3535

EMDN P07040302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08720214006866 Basic UDI-DIDate27 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
HeartR™ ASD Occluder
Model / Reference
LEFS3535
Primary DI / UDI-DI
08720214006866
Basic UDI-DI
B-08720214006866
EMDN Code
P07040302 Cardiac occluders, atrial septal defects
Device Class
Class III
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
NL-MF-000005742

Other devices from LifeTech Scientific (Europe) B.V.

See all devices from LifeTech Scientific (Europe) B.V. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 140a1e7a-3b79-43b5-bf84-b7d9e5728782 61 fields · synced 22 Oct 2026