GEM Premier 3500 iQM - pH, pCO2, pO2, Hct, Na+, K+, Ca++ (450 Tests)

Name: GEM Premier 3500 iQM - pH, pCO2, pO2, Hct, Na+, K+, Ca++ (450 Tests)
Brand: Instrumentation Laboratory Company
SKU: 08426950508632

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

Identification

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.

SRN US-MF-000035586

US · Bedford

manufacturer

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

Name	UDI-DI	Certificate
GEM Premier 3500 iQM - pH, pCO2, pO2, Hct, Na+, K+, Ca++ (150 Tests)	08426950511601	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
GEM Premier 3500 iQM - pH, pCO2, pO2, Hct, Na+, K+, Ca++ (300 Tests)	08426950511632	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
GEM Premier 3500 iQM - pH, pCO2, pO2, Hct, Na+, K+, Ca++ (600 Tests)	08426950511687	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
GEM Premier 3500 iQM - pH, pCO2, pO2, Hct, Na+, K+, Ca++ (75 Tests)	08426950511564	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
GEM Premier 3500 iQM - pH, pCO2, pO2, Hct, Na+, K+, Ca++ (75 Tests)	08426950511571	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED