Skip to content

GamCath

by Baxter Healthcare SA 14 variants

Ref MC-GDHK-1115

Expiring European Union

CE MDR

Valid until

31 Jul 2027

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number00854120000000000000081JC Basic UDI-DI 00085412946146UDI-DIDate22 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 056740 0013 Expiring Expires in 273 days

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    1 Aug 2022
    Expires
    31 Jul 2027

Coverage

1 jurisdiction

NorwaySwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumAustriaRomaniaSloveniaPortugalSpainItalyCroatiaGreeceCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Expiring

Map note: Northern Ireland has no dot of its own.

  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovenia
  • Spain
  • Sweden

Specification

EUDAMED

Device Name
Gamcath HighFlow Dolphin Protect Catheter kits
Model / Reference
MC-GDHK-1115
Primary DI / UDI-DI
00085412946146
Basic UDI-DI
00854120000000000000081JC
EMDN Code
F900201 Temporary hemodialysis catheters and kits
Device Class
Class III
EU 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