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UDI Compass
Certificate valid

Snapshot 2026-10-19 · Link to EUDAMED

TruSight™ Oncology Comprehensive (DRAGEN)

UDI-DI 00816270020934Basic UDI-DI 0081627002TSODGTX

Class C · IVDR · Illumina, Inc.

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

IVDR 821502

EU technical documentation assessment · valid

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-04-28 · Expiry 2031-04-27

Scope not stated in certificate data.

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

Manufacturer

Illumina, Inc.

SRN US-MF-000013476

US · San Diego

manufacturer

Authorised representative: Illumina Netherlands B.V. (NL-AR-000012614)

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/trusighttm-oncology-comprehensive-dragen-0934 · UDI page: /udi/00816270020934

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