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Guardant360 CDx

by Guardant Health Inc United States EUDAMED

Ref GHM0108

EMDN W010699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberV75 099042 0005 Date1 Oct 2026IssuedStatusActive expires 15 May 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V75 099042 0005 Supplemented

    Technical documentation EU IVDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    1 Oct 2026
    Expires
    15 May 2029
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Guardant360 CDx
Model / Reference
GHM0108
Primary DI / UDI-DI
00850002748086
Basic UDI-DI
0850002748G360CDxHM
EMDN Code
W010699 Genetic tests - other
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000028320
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Guardant Health, Inc.

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
  • Companion Diagnostics
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED b7f2a379-2ebb-490b-b77d-01b79744284c 61 fields · synced 24 Oct 2026