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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 4 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TCM4x Cable | 903-339 | FDA UDI | Class II | Active |
| Contact gel | 0603210 | FDA UDI | Class II | Active |
| safePICO70 | 956-615 | FDA UDI | Class II | Active |
| REF 943-696 S5332 Cleaning Solution - Alcaline | 943-696 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-733 | FDA UDI | Class II | Unknown |
| ABL77 Sci | 945-638 | FDA UDI | Class II | Unknown |
| Calibration Solution | 944-069 | FDA UDI | Class II | Unknown |
| SafeClinitube D941P-NA-240-55 | 942-889 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-726 | FDA UDI | Class II | Active |
| Electrode for ABL analyzers | 945-616 | FDA UDI | Class II | Active |
| Electrode for ABL analyzers | 945-620 | FDA UDI | Class II | Active |
| Pico70 | 956-546 | FDA UDI | Class II | Unknown |
| Qualicheck 4+, Level 3 | 944-055 | FDA UDI | Class I | Active |
| Pico70 | 956-518 | FDA UDI | Class II | Active |
| Clinitubes D957g-70-210x5 | 942-884 | FDA UDI | Class I | Unknown |
| REF 905-917 ABL90 FLEX sBOX | 905-917 | FDA UDI | Class II | Unknown |
| Pico50 | 956-552 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-771 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-704 | FDA UDI | Class II | Active |
| KAPILLARRØRS ADAP. 85 stk. PAK | 906-018 | FDA UDI | Class I | Active |
| Qualicheck 4+, Level 2 | 944-054 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-671 | FDA UDI | Class II | Active |
| safePICO70 | 956-612 | FDA UDI | Class II | Active |
| ABL77 Sci | 945-653 | FDA UDI | Class II | Unknown |
| Rinse Solution S4980 REF 944-130 | 944-130 | FDA UDI | Class II | Active |
| Calibration Solution | 943-837 | FDA UDI | Class II | Unknown |
| Electrode for ABL analyzers | 945-619 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-672 | FDA UDI | Class II | Active |
| safePICO70 | 956-609 | FDA UDI | Class II | Active |
| TCM4 combi module, TCpO2/O2 combi module | 902-778 | FDA UDI | Class II | Active |
| S5362 Ref 943-906 | 943-906 | FDA UDI | Class II | Active |
| Passthrough cable, For TC electrodes | 905-751 | FDA UDI | Class II | Active |
| Abl90 Flex Sp90 | 944-157 | FDA UDI | Class II | Active |
| Pico70 | 956-522 | FDA UDI | Class II | Active |
| ABL80 FLEX CO-OX Analyzer | 393-841 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-710 | FDA UDI | Class II | Active |
| Electrode for ABL analyzers | 945-663 | FDA UDI | Class II | Active |
| Autocheck 6+, Level 1, S7835 | 944-094 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-806 | FDA UDI | Class II | Active |
| Autocheck 3+, Level 4, S7365 | 944-085 | FDA UDI | Class I | Active |
| Qualicheck 5+, Level 4 | 944-020 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-688 | FDA UDI | Class II | Active |
| Autocheck 6+, Level 4, S7865 | 944-097 | FDA UDI | Class I | Active |
| Clinitubes D941g-80-140x5 | 942-882 | FDA UDI | Class I | Unknown |
| ABL77 Sci | 945-640 | FDA UDI | Class II | Unknown |
| Electrode for ABL analyzers | 945-605 | FDA UDI | Class II | Active |
| 925-047 ABL90 FLEX inlet clip | 925-047 | FDA UDI | Class II | Active |
| ABL77 Sci | 945-642 | FDA UDI | Class II | Unknown |
| Electrode for ABL analyzers | 945-375 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-677 | FDA UDI | 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