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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-25 · Link to EUDAMED

i-STAT PTplus Control Level 1

UDI-DI 00054749004843Basic UDI-DI 0054749BSW0001GU

Class C · IVDR · Abbott Point of Care Inc.

Identification
Model
06P17-17
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

3830507TD01

EU technical documentation assessment · unknown

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

Valid from 2023-12-14 · Expiry 2028-10-27

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-ptplus-control-level-1-4843 · UDI page: /udi/00054749004843

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