Skip to content

GamCath

by Vantive Health GmbH 63 variants

Ref GDK-815P

Active European Union

CE MDR

Valid until

14 Nov 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

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 Number7332414VA0000483B Basic UDI-DI 07332414200954UDI-DIDate15 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
GamCath Dialysis Catheter Double Lumen Kits
Model / Reference
GDK-815P
Primary DI / UDI-DI
07332414200954
Basic UDI-DI
7332414VA0000483B
EMDN Code
F900201 Temporary hemodialysis catheters and kits
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CH-MF-000038981
Authorised representative
Vantive S.r.l. IT-AR-000041309

Other devices from Vantive Health GmbH

See all devices from Vantive Health GmbH →

Properties

  • Sterile
  • CMR Substance

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No