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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 6 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| REF 905-956 ABL90 FLEX sBOX PLUS | 905-956 | FDA UDI | Class II | Unknown |
| ABL90 Sensor Cassette pack | 946-013 | FDA UDI | Class II | Active |
| Cleaning Solution with additive S8375 REF 944-126 | 944-126 | FDA UDI | Class I | Active |
| safePICO70 | 956-614 | FDA UDI | Class II | Active |
| ABL77 Sci | 945-651 | FDA UDI | Class II | Unknown |
| Clinitubes D941g-240-85x5 | 942-875 | FDA UDI | Class I | Unknown |
| TC pO2/pCO2 Membraning kit For TC electrode | 904-892 | FDA UDI | Class II | Active |
| Adhesive rings N20 kit | 905-872 | FDA UDI | Class II | Active |
| TOSCA Fixation rings (60x) | 5601500 | FDA UDI | Class II | Active |
| Calibration Solution 2 | 944-129 | FDA UDI | Class II | Active |
| Autocheck 6+, Level 2, S7845 | 944-095 | FDA UDI | Class I | Active |
| Calibration gas 1 | 962-140 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-687 | FDA UDI | Class II | Unknown |
| safeClinitubes D957P-70-45 | 942-969 | FDA UDI | Class I | Active |
| Clinitubes D941g-Na-240-85x10 | 942-876 | FDA UDI | Class I | Unknown |
| Extension cable For TCM3 electrodes, 3m | 617-853 | FDA UDI | Class II | Active |
| Clinitubes D957g-70-35x5 | 942-869 | FDA UDI | Class I | Unknown |
| Membrane for E755 electrode | 942-062 | FDA UDI | Class II | Active |
| Membraning kit for tc sensor 54 | 905-868 | FDA UDI | Class II | Active |
| Gas mixture cylinder | 962-106 | FDA UDI | Class I | Active |
| Range+ Qualicheck Lev. 2 S7940 | 944-152 | FDA UDI | Class I | Active |
| Clinitubes D956g-70-35*1 | 905-661 | FDA UDI | Class I | Unknown |
| D155 - REF 905-248 Disposable Waste Container | 905-248 | FDA UDI | Class II | Unknown |
| QC Adaptor | 925-214 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-678 | FDA UDI | Class II | Unknown |
| 944-071 Rinse Solution S4930 for ABL5 | 944-071 | FDA UDI | Class II | Unknown |
| Abl80 Flex Sp80 Co-Ox | 944-252 | FDA UDI | Class II | Active |
| High Metabolite Qc, Level 1 | 944-099 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-730 | FDA UDI | Class II | Unknown |
| Range+ Qualicheck Lev. 3 S7950 | 944-153 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-689 | FDA UDI | Class II | Active |
| Qualicheck 4+, Level 4 | 944-056 | FDA UDI | Class I | Active |
| Electrode for ABL analyzers | 945-612 | FDA UDI | Class II | Active |
| Calibration Solution 1 | 944-127 | FDA UDI | Class II | Active |
| Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3 | K130236 | FDA 510(k) | Class I | Active |
| Hematocrit and Metabolite QUALICHECK | K150226 | FDA 510(k) | Class I | Active |
| Abl800 Flex With Flexq Module, Model Abl8xx | K043218 | FDA 510(k) | Class II | Active |
| ABL90 FLEX PLUS System | K252488 | FDA 510(k) | Class II | Active |
| Aqt90 Flex Analyzer, Aqt90 Flex Myoglobin Test Kit, Aqt90 Flex Lqc Multi-Check, Lvls 1-3, Aqt90 Flex Myo Cal Cartridge.. | K112161 | FDA 510(k) | Class I | Active |
| ABL800 FLEX with AQURE connectivity | K142898 | FDA 510(k) | Class II | Active |
| Abl90 Flex | K132691 | FDA 510(k) | Class I | Active |
| Modification To Abl800 Flex | K050869 | FDA 510(k) | Class II | Active |
| Tcm400 | K001866 | FDA 510(k) | Class II | Active |
| Abl90 Flex | K122642 | FDA 510(k) | Class II | Active |
| High Metabolite Qualicheck | K130415 | FDA 510(k) | Class I | Active |
| ABL90 FLEX PLUS System, safeCLINITUBES | K252207 | FDA 510(k) | Class II | Active |
| Tcm40 Monitoring System | K043003 | FDA 510(k) | Class II | Active |
| Abl90 Flex Plus | K160153 | FDA 510(k) | Class II | Active |
| Abl90 Flex | K122729 | FDA 510(k) | Class II | Active |
| Abl835 Flex Analyzer With Pleural Ph | K110416 | FDA 510(k) | Class II | Active |
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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