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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 1 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| D159 - REF 905-425 Reusable Waste Container | 905-425 | FDA UDI | Class II | Unknown |
| safePICO70 | 956-624 | FDA UDI | Class II | Active |
| Autocheck 3+, Level 1, S7335 | 944-082 | FDA UDI | Class I | Active |
| Clot catcher | 906-016 | FDA UDI | Class II | Unknown |
| Crea Calibration Solution 1 | 944-135 | FDA UDI | Class II | Active |
| S8377 REF 944-136 *6 Cleaning solution Met II Solution | 944-136 | FDA UDI | Class II | Active |
| TC electrode | 904-308 | FDA UDI | Class II | Active |
| Calibration Gas 2 | 962-175 | FDA UDI | Class II | Active |
| Hematocrit S7170 Qc Level 1 | 944-039 | FDA UDI | Class I | Active |
| Cable fixation clips (5x) | 5601010 | FDA UDI | Class II | Active |
| Calibration Solution | 944-021 | FDA UDI | Class II | Active |
| TC electrode | 945-660 | FDA UDI | Class II | Unknown |
| safePICO | 956-623 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-731 | FDA UDI | Class II | Active |
| Abl800 Flex | 393-800 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-770 | FDA UDI | Class II | Active |
| Pico70 | 956-529 | FDA UDI | Class II | Active |
| Range+ Qualicheck Lev. 1 S7930 | 944-151 | FDA UDI | Class I | Active |
| CAPILLARY CAPS, green 110pcs. | 904-453 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-773 | FDA UDI | Class II | Unknown |
| Clot catcher | 906-020 | FDA UDI | Class II | Active |
| tc Sensor 54 | 945-736 | FDA UDI | Class II | Active |
| Membrane for E788 electrode | 942-063 | FDA UDI | Class II | Active |
| Membrane for E909 electrode | 942-042 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-727 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-712 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-707 | FDA UDI | Class II | Active |
| ABL77 Sci | 945-654 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-686 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-681 | FDA UDI | Class II | Active |
| Membrane for E744 electrode | 942-061 | FDA UDI | Class II | Active |
| Abl80 Flex Sp80 | 944-174 | FDA UDI | Class II | Active |
| ABL77 Sci | 945-652 | FDA UDI | Class II | Unknown |
| Electrode for ABL analyzers | 945-376 | FDA UDI | Class II | Unknown |
| ABL77 Sci | 945-637 | FDA UDI | Class II | Unknown |
| S7735 Autocheck Tm 5+, Level 1 | 944-074 | FDA UDI | Class I | Active |
| ABL90 Sensor Cassette pack | 946-060 | FDA UDI | Class II | Active |
| Abl800 Flex | 393-801 | FDA UDI | Class II | Active |
| Fixation Kit For TC electrodes | 904-891 | FDA UDI | Class II | Active |
| CAPILLARY CAPS, RED 160pcs. | 904-439 | FDA UDI | Class I | Active |
| safePICO70 | 956-613 | FDA UDI | Class II | Active |
| TOSCA preparation supplies | 5601100 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-702 | FDA UDI | Class II | Active |
| Abl90 Flex Sp90 | 944-457 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-675 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-724 | FDA UDI | Class II | Unknown |
| Accessories starter kit for ABL800 FLEX | 905-834 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-679 | FDA UDI | Class II | Unknown |
| Safe Clinit. D941p-Na-240-85x3 | 942-891 | FDA UDI | Class I | Active |
| Clinitubes D957g-70-100x5 | 942-878 | FDA UDI | Class I | Unknown |
Related Companies
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Authorities
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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