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RheOx Catheter

by Galvanize Therapeutics, Inc. United States EUDAMED

Ref GTI-00005-01 EMDN R070180

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00860007903427 Basic UDI-DIDate2 Sep 2022RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
GTI-00005-01
Primary DI / UDI-DI
00860007903427
Basic UDI-DI
B-00860007903427
EMDN Code
R070180 Bronchopulmonary endoscopy probes, single-use - accessories
Device Class
Class IIa
Market of Registration
Italy

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
  • Sterile
Other properties (10)
  • Implantable: No
  • 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 1d5236c7-dd95-4074-bff2-b7db9148bea6 61 fields · synced 25 Oct 2026