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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

Guardant360 CDx

UDI-DI 00850002748086Basic UDI-DI 0850002748G360CDxHM

Class C · IVDR · Guardant Health Inc

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

V75 099042 0005

EU technical documentation assessment · unknown

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-10-01 · Expiry 2029-05-15

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Guardant Health Inc

SRN US-MF-000028320

US · Redwood City

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/guardant360-cdx-8086 · UDI page: /udi/00850002748086

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