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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Atellica IM Hepatitis B surface Antigen II Confirmatory (HBsII Conf)

UDI-DI 00630414599267Basic UDI-DI 0405686901881WC

Class D · IVDR · Siemens Healthcare Diagnostics Inc.

Identification
Model
IVDR_67_TTN_DUB-C_D_REAG_HBsAg Confirmatory
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IX 1290554-36

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2025-07-14 · Expiry 2030-07-13

Scope not stated in certificate data.

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

Manufacturer

Siemens Healthcare Diagnostics Inc.

SRN US-MF-000016560

US · Tarrytown

manufacturer

Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited (IE-AR-000006763)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/atellica-im-hepatitis-b-surface-antigen-ii-confirmatory-hbsi-9267 · UDI page: /udi/00630414599267

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