EUDAMED device
GEM Premier 7000 with iQM3
EUDAMED device 00195226000924 · Instrumentation Laboratory Company
Key facts
| Primary DI | 00195226000924 |
|---|---|
| Trade name | GEM Premier 7000 with iQM3 |
| Device name | GEM Premier 7000 with iQM3 |
| Reference or catalog number | 00000015279 |
| Model | 00000015279 |
| Manufacturer | Instrumentation Laboratory Company |
| Manufacturer SRN | US-MF-000035586 |
| Risk class | Class A |
| EMDN code | W0201040102 |
| EMDN description | BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters) |
| Legislation | ivdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Dec 28, 2023 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: