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Sign in to claim this brandRadiometer Medical ApS
US
Last updated May 24, 2026
What Radiometer Medical ApS makes
Radiometer Medical ApS produces in vitro diagnostics (IVDs) for blood gas analysis, haemoximetry, and electrolyte measurement, including portable and benchtop analysers, control materials, calibrators, and consumables like sampling kits and capillary tubes. Their portfolio also includes transcutaneous blood gas monitoring sensors, electrical connection cables for medical devices, and clinical chemistry analysers for metabolic profiling. Additional products encompass cleaning solutions for medical devices and calibration gases for analytical instruments.
The company’s devices are classified under FDA categories as Class I and Class II, with regulatory submissions documented via 510(k) premarket notifications and Unique Device Identifiers (UDIs). These products are listed in the FDA’s regulatory databases, ensuring compliance with US medical device regulations. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- radiometer.dk
- —
- —
- [email protected]
- Phone
- +459999999999
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 308667539
Catalogue (319)
Page 2 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fixation kit N20 | 905-873 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-721 | FDA UDI | Class II | Unknown |
| Disposable Waste Container D513 REF 905-802 | 905-802 | FDA UDI | Class II | Active |
| Calibration Gas 2 | 962-141 | FDA UDI | Class II | Unknown |
| Safe Clinit. D957p-70-125x1 | 942-893 | FDA UDI | Class I | Active |
| safePICO70 | 956-610 | FDA UDI | Class II | Active |
| Cleaning Solution with additive S7375 REF 944-123 | 944-123 | FDA UDI | Class I | Unknown |
| S7765 Autocheck Tm 5+, Level 4 | 944-077 | FDA UDI | Class I | Active |
| Calibration Gas 2 | 962-096 | FDA UDI | Class II | Unknown |
| Safe Clinit. D941p-240-85x1 | 942-890 | FDA UDI | Class I | Active |
| ABL77 Sci | 945-695 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-715 | FDA UDI | Class II | Active |
| Pico70 | 956-533 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-717 | FDA UDI | Class II | Unknown |
| TC pO2/pCO2 Membraning kit For TC electrode | 905-805 | FDA UDI | Class II | Active |
| Extension cable For TCM3 electrodes, 6m | 617-864 | FDA UDI | Class II | Active |
| Electrode for ABL analyzers | 945-618 | FDA UDI | Class II | Active |
| Unassembled connector kit For hyperbaric chamber | 905-660 | FDA UDI | Class II | Active |
| Attachment clips | 5601110 | FDA UDI | Class II | Active |
| ABL90 Sensor Cassette pack | 946-005 | FDA UDI | Class II | Active |
| ABL77 Sci | 945-639 | FDA UDI | Class II | Unknown |
| TOSCA sensor 92 | 5621000 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-714 | FDA UDI | Class II | Active |
| Electrode for ABL analyzers | 945-603 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-685 | FDA UDI | Class II | Active |
| Connector kit For ETC hyperbaric chamber | 905-688 | FDA UDI | Class II | Active |
| Membraning kit for tc sensor 84 | 905-871 | FDA UDI | Class II | Active |
| O2 module for the TCM4XX Series | 902-564 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-703 | FDA UDI | Class II | Unknown |
| Qualicheck 4+, Level 1 | 944-053 | FDA UDI | Class I | Active |
| Safe Clinitubes D957p-70-70x1 | 942-898 | FDA UDI | Class I | Active |
| Calibration Gas | 962-188 | FDA UDI | Class II | Active |
| tc Sensor 84 | 945-737 | FDA UDI | Class II | Active |
| Electrode for ABL analyzers | 945-662 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-716 | FDA UDI | Class II | Unknown |
| Pico70 | 956-547 | FDA UDI | Class II | Active |
| Calibration Solution | 943-839 | FDA UDI | Class II | Unknown |
| Electrolyte 54 | 905-866 | FDA UDI | Class II | Active |
| Membrane for E808 electrode | 942-043 | FDA UDI | Class II | Unknown |
| ABL90 Sensor Cassette pack | 946-010 | FDA UDI | Class II | Active |
| Electrode for ABL analyzers | 945-633 | FDA UDI | Class II | Unknown |
| Membrane for E799 electrode | 942-064 | FDA UDI | Class II | Active |
| Disposable Waste Container D512 REF 905-590 | 905-590 | FDA UDI | Class II | Unknown |
| Membrane for E733 electrode | 942-060 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-718 | FDA UDI | Class II | Unknown |
| Hematocrit S7180 Qc Level 2 | 944-040 | FDA UDI | Class I | Active |
| Autocheck 3+, Level 2, S7345 | 944-083 | FDA UDI | Class I | Active |
| Sc90 50 Bg, Lyt, Met, Oxi + Qc | 946-050 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-674 | FDA UDI | Class II | Active |
| ABL77 Sci | 945-644 | FDA UDI | Class II | Unknown |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Radiometer Medical Aps BROENSHOEJ Hovedstaden · DK FEI 3002807968