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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Atellica IM HBc Total 2 (HBcT2)

UDI-DI 00630414604138Basic UDI-DI 0405686901498W9

Class D · IVDR · Siemens Healthcare Diagnostics Products Ltd.

Identification
Model
IVDR_67_LLB_DUB-C_D_KIT_HBc Total 2
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IX 7091840-1

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2025-01-29 · Expiry 2028-10-23

Scope not stated in certificate data.

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

Manufacturer

Siemens Healthcare Diagnostics Products Ltd.

SRN GB-MF-000016339

UK · Llanberis, Gwynedd

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-hbc-total-2-hbct2-4138 · UDI page: /udi/00630414604138

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