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UDI Compass
Certificate valid

Snapshot 2026-10-25 · Link to EUDAMED

i-STAT hs-TnI Control Level 2

UDI-DI 00054749004935Basic UDI-DI 0054749SJT0001M7

Class C · IVDR · Abbott Point of Care Inc.

Identification
Model
06P17-21
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

3837587TD01

EU technical documentation assessment · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2025-08-22 · Expiry 2030-08-22

Scope not stated in certificate data.

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

Manufacturer

Abbott Point of Care Inc.

SRN US-MF-000038604

US · Princeton

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/i-stat-hs-tni-control-level-2-4935 · UDI page: /udi/00054749004935

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