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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 5 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Abl80 Sc80 | 945-708 | FDA UDI | Class II | Active |
| Autocheck 6+, Level 3, S7855 | 944-096 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-728 | FDA UDI | Class II | Active |
| TC contact liquid | 905-689 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-693 | FDA UDI | Class II | Unknown |
| TCM4x Cable | 903-182 | FDA UDI | Class II | Active |
| Calibration gas 1 | 962-174 | FDA UDI | Class II | Active |
| TCM4x Cable | 903-180 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-673 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-667 | FDA UDI | Class II | Unknown |
| Electrode for ABL analyzers | 945-614 | FDA UDI | Class II | Active |
| S7745 Autocheck Tm 5+, Level 2 | 944-075 | FDA UDI | Class I | Active |
| Membrane for E722 electrode | 942-059 | FDA UDI | Class II | Active |
| D941g-240-55x5 | 942-885 | FDA UDI | Class I | Unknown |
| Abl80 Sc80 | 945-843 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-734 | FDA UDI | Class II | Unknown |
| safePICO70 | 956-616 | FDA UDI | Class II | Active |
| Membrane for E1001 electrode | 942-058 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-691 | FDA UDI | Class II | Unknown |
| Membrane for E7066 electrode | 942-065 | FDA UDI | Class II | Active |
| TCM TOSCA module | 903-044 | FDA UDI | Class II | Active |
| Electrolyte 84 | 905-869 | FDA UDI | Class II | Active |
| Qualicheck 5+, Level 1 | 944-017 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-720 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-683 | FDA UDI | Class II | Unknown |
| Aqure | 933-599 | FDA UDI | Class I | Active |
| COMBI electrolyte | 0604210 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-666 | FDA UDI | Class II | Active |
| S4970 Rinse 1 Solution for 600mL, for ABL7xx | 944-057 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-711 | FDA UDI | Class II | Unknown |
| Calibration gas 1 | 962-169 | FDA UDI | Class II | Unknown |
| Calibration Gas 2 | 962-170 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-713 | FDA UDI | Class II | Active |
| Crea Calibration Solution 1 | 944-133 | FDA UDI | Class II | Active |
| TCM 4 series ETX base unit | 391-880 | FDA UDI | Class II | Active |
| Calibration Solution | 944-024 | FDA UDI | Class II | Unknown |
| TCM4XX ETX VueLink adapter, cable for TCM4XX ETX | 636-651 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-680 | FDA UDI | Class II | Active |
| ABL80 CO-OX Capillary adapter | 906-025 | FDA UDI | Class II | Active |
| Abl77 Capillary Adapters | 906-022 | FDA UDI | Class I | Active |
| Calibration Solution | 944-025 | FDA UDI | Class II | Unknown |
| safePICO Aspirator | 956-622 | FDA UDI | Class II | Active |
| TC pO2/pCO2 electrode | 945-377 | FDA UDI | Class II | Active |
| TC sensor, Fixation kit | 905-836 | FDA UDI | Class II | Active |
| TCM4x Cable | 903-340 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-722 | FDA UDI | Class II | Active |
| ABL77 Sci | 945-641 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-768 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-769 | FDA UDI | Class II | Unknown |
| Attachment clips (40x) | 5601300 | FDA UDI | Class II | Active |
Related Companies
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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