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UDI Compass
Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

GEM Premier 3500 iQM - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose, and Lactate (150 Tests)

UDI-DI 08426950511618Basic UDI-DI 84269505116947E

Class C · IVDR · Instrumentation Laboratory Company

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IVDR 727654

EU technical documentation assessment · valid

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-11-01 · Expiry 2031-10-31

Scope not stated in certificate data.

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

Manufacturer

Instrumentation Laboratory Company

SRN US-MF-000035586

US · Bedford

manufacturer

Authorised representative: Instrumentation Laboratory SpA (IT-AR-000008169)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/gem-premier-3500-iqm-ph-pco2-po2-hct-na-k-ca-glucose-and-lac-1618 · UDI page: /udi/08426950511618

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