FDA device listing
905-802 D513 Disposable Waste Container,944-127 S1820 Calibration Solution 1,944-130 S4980 Rinse Solution,944-136 S8377…
FDA device listing 2034618313 · RADIOMETER MEDICAL APS
Key facts
| Proprietary names | 905-802 D513 Disposable Waste Container,944-127 S1820 Calibration Solution 1,944-130 S4980 Rinse Solution,944-136 S8377 Cleaning Solution Met II Solution,944-155 Rinse Solution II S4987 600mL |
|---|---|
| Owner/operator | RADIOMETER MEDICAL APS |
| Owner/operator number | 8020503 |
| Product codes | CEM, CGA, CGZ, CHL, CIG, GHS, JFP, JGS, KHP, KQI, MQM |
| Device names | CEM - Electrode, Ion Specific, Potassium, CGA - Glucose Oxidase, Glucose, CGZ - Electrode, Ion-Specific, Chloride, CHL - Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, CIG - Diazo Colorimetry, Bilirubin, GHS - Assay, Carboxyhemoglobin, JFP - Electrode, Ion Specific, Calcium, JGS - Electrode, Ion Specific, Sodium, KHP - Acid, Lactic, Enzymatic Method, KQI - Assay, Fetal Hemoglobin, MQM - Bilirubin (Total And Unbound) In The Neonate Test System |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1110, 862.1113, 862.1120, 862.1145, 862.1170, 862.1345, 862.1450, 862.1600, 862.1665, 864.7425, 864.7455 |
| Review panels | Clinical Chemistry, Hematology |
| Registered establishments | Radiometer Solutions Sp. z o.o. |
| Establishment registrations | 3013513377 |
| FEI numbers | 3013513377 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database