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HeartR

by LifeTech Scientific (Europe) B.V. 88 variants

Ref LEFD0810

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Overview

Introducing the HeartR PDA Occluder, a revolutionary medical device designed to treat patients with heart valve disorders. With its unique endocrine disruptor-free technology and companion diagnostics capabilities, this device offers unparalleled care for those in need.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08720214006910 Basic UDI-DI 08720214006910UDI-DIDate2 Aug 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
LEFD0810
Primary DI / UDI-DI
08720214006910
Basic UDI-DI
B-08720214006910
EMDN Code
P07040303 Cardiac occluders, foramen ovale and botallo duct
Device Class
Class III
EU market of registration
Austria

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

  • 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