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UDI Compass

cobas lumira SARS-CoV-2 Ag Ultra

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 07613336238189Basic UDI-DI 761333603252AP

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Class B · IVDR · Roche Diagnostics GmbH

Identification

Model
—
Issuing agency
GS1
Device status
active
Sterile
No

Certificates

V76 010283 0742

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-08-14 · Expiry 2031-08-13

Scope not stated in certificate data.

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

Manufacturer

Roche Diagnostics GmbH

SRN DE-MF-000006260

DE · Mannheim

manufacturer

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/cobas-lumira-sars-cov-2-ag-ultra-8189 · UDI page: /udi/07613336238189

All devices from Roche Diagnostics GmbH