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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Elecsys Anti-HBs II

UDI-DI 07613336160350Basic UDI-DI 761333603411AK

Class D · IVDR · Roche Diagnostics GmbH

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

V76 010283 0739

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-09-14 · Expiry 2031-09-13

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/elecsys-anti-hbs-ii-0350 · UDI page: /udi/07613336160350

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