Certificate valid

Snapshot 2026-10-17 · Link to EUDAMED

Hema-Combistix

UDI-DI 00630414985046Basic UDI-DI 0405686901962WD

Class B · IVDR · Siemens Healthcare Diagnostics Inc.

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Identification

Model: IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Stat
EMDN: W0101060205
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

IX 1290554-7

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2025-05-12 · Expiry 2028-06-05

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)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hema-combistix-5046 · UDI page: /udi/00630414985046

All devices from Siemens Healthcare Diagnostics Inc.

Scan an inventory CSV