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WAVE 1 Activation Materials

by Galvanize Therapeutics, Inc. United States EUDAMED

Ref GTI-00036 EMDN C020399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850033727GTI-00036B8 Basic UDI-DIDate28 Aug 2023RegisteredStatusWithdrawn

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  • Withdrawn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European Union — CE/MDR Withdrawn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 24 Oct 2026

Model / Reference
GTI-00036
Primary DI / UDI-DI
00850033727005
Basic UDI-DI
0850033727GTI-00036B8
EMDN Code
C020399 Cardiac tissue ablation devices - other
Device Class
Class IIb
Medical Purpose
The WAVE 1 activation material is intended to provide support for the CENTAURI generator to deliver WAVE 1

Manufacturer details

EUDAMED SRN
US-PR-000036570

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 (1)
  • Sterile: No

Sources (1)

  • EUDAMED 52fd1dd3-ede0-42ee-8ac0-fcf142619c33 61 fields · synced 24 Oct 2026