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GamCath

by Baxter Healthcare SA EUDAMED

Active European Union

Ref MC-GDHK-1317,5

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number00854120000000000000081JC Basic UDI-DIDate22 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Device Name
Gamcath HighFlow Dolphin Protect Catheter kits
Model / Reference
MC-GDHK-1317, 5
Primary DI / UDI-DI
00085412946221
Basic UDI-DI
00854120000000000000081JC
EMDN Code
F900201 Temporary hemodialysis catheters and kits
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CH-MF-000026124
Authorised representative
Baxter Deutschland GmbH DE-AR-000010308

Other devices from Baxter Healthcare SA

See all devices from Baxter Healthcare SA →

Properties

  • Sterile

Other properties (12)

  • 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