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Compatibility Cable, BW ThermoCool ST

by Galvanize Therapeutics, Inc. United States EUDAMED

Ref GTI-00038 EMDN C020399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850033727GTI-00038BC Basic UDI-DIDate5 Jun 2024RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
GTI-00038
Primary DI / UDI-DI
00850033727043
Basic UDI-DI
0850033727GTI-00038BC
Direct Marketing DI
00850033727043
EMDN Code
C020399 Cardiac tissue ablation devices - other
Device Class
Class I
Market of Registration
Croatia

Manufacturer details

EUDAMED SRN
US-MF-000012701
Authorised representative
Galvanize Therapeutics Germany GmbH DE-AR-000035678

Other devices from Galvanize Therapeutics, Inc.

See all devices from Galvanize Therapeutics, Inc. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED b118d7f6-9913-42a7-87d8-25b171872a29 61 fields · synced 25 Oct 2026