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Heart Hugger

by General Cardiac Technology, Inc. 4 variants

Ref GT1500-LargeModel Heart Hugger Sternum Support Harness

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08678390004HH001V4 Basic UDI-DI 00867839000423UDI-DIDate8 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Heart Hugger Sternum Support Harness
Model / Reference
Heart Hugger Sternum Support Harness, GT1500-Large
Primary DI / UDI-DI
00867839000423
Basic UDI-DI
08678390004HH001V4
EMDN Code
Y0699 External prostheses and orthoses - other
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000033435
Authorised representative
ICON (LR) Limited IE-AR-000006507

From the manufacturer

Manufacturer's product page: About Heart Hugger

Other devices from General Cardiac Technology, Inc.

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • 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