Is this your brand? Sign in to claim ownership.
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 3 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 905-918 ABL90 FLEX flush device | 905-918 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-725 | FDA UDI | Class II | Active |
| ABL77 Sci | 945-636 | FDA UDI | Class II | Unknown |
| Qualicheck 5+, Level 2 | 944-018 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-676 | FDA UDI | Class II | Active |
| Calibration Solution | 944-064 | FDA UDI | Class II | Unknown |
| D8088+D8089 Crea membrane A+B | 942-073 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-719 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-700 | FDA UDI | Class II | Active |
| ABL90 FLEX Analyzer | 393-090 | FDA UDI | Class II | Active |
| Pico70 | 956-519 | FDA UDI | Class II | Unknown |
| Safe Clinit. D957p-70-100x1 | 942-892 | FDA UDI | Class I | Active |
| Electrode for ABL/BPH5 analyzers | 945-383 | FDA UDI | Class II | Unknown |
| ABL90 Sensor Cassette pack | 946-009 | FDA UDI | Class II | Active |
| Crea Calibration Solution 2 | 944-134 | FDA UDI | Class II | Active |
| TCM4XX ETX Analog adapter cable for TCM4XX ETX | 636-650 | FDA UDI | Class II | Active |
| ABL90 FLEX PLUS Analyzer | 393-092 | FDA UDI | Class I | Active |
| Membrane for E155 electrode | 942-067 | FDA UDI | Class II | Unknown |
| ABL90 Sensor Cassette pack | 946-008 | FDA UDI | Class II | Active |
| Abl80 Flex Sp80 | 944-341 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-690 | FDA UDI | Class II | Active |
| Membrane for E7077 electrode | 942-066 | FDA UDI | Class I | Active |
| TC electrode | 945-655 | FDA UDI | Class II | Active |
| Pico70 | 956-525 | FDA UDI | Class II | Active |
| Calibration Solution 1 | 944-128 | FDA UDI | Class II | Active |
| Rinse Solution II S4987 REF 944-155 600mL | 944-155 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-665 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-709 | FDA UDI | Class II | Unknown |
| S53516 10mL REF 943-905 Electrode Cleaner | 943-905 | FDA UDI | Class II | Unknown |
| Qualicheck 5+, Level 3 | 944-019 | FDA UDI | Class I | Active |
| Pico70 | 956-534 | FDA UDI | Class II | Unknown |
| Electrode for ABL analyzers | 945-613 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-705 | FDA UDI | Class II | Unknown |
| ABL77 Sci | 945-643 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-729 | FDA UDI | Class II | Unknown |
| TCM4x Cable | 903-181 | FDA UDI | Class II | Unknown |
| Abl80 Sc80 | 945-732 | FDA UDI | Class II | Unknown |
| Electrode for ABL analyzers | 945-617 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-701 | FDA UDI | Class II | Active |
| safePICO70 | 956-608 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-668 | FDA UDI | Class II | Active |
| TCM4XX ETX Serial adapter, cable for TCM4XX ETX | 636-649 | FDA UDI | Class II | Active |
| ABL90 FLEX, Clot catcher | 906-026 | FDA UDI | Class II | Active |
| Abl80 Sc80 | 945-670 | FDA UDI | Class II | Active |
| Autocheck 3+, Level 3, S7355 | 944-084 | FDA UDI | Class I | Active |
| TCM CombiM module | 903-111 | FDA UDI | Class II | Active |
| ABL80 FLEX Analyzer | 393-839 | FDA UDI | Class II | Unknown |
| Electrode for ABL analyzers | 945-615 | FDA UDI | Class II | Active |
| S7755 Autocheck Tm 5+, Level 3 | 944-076 | FDA UDI | Class I | Active |
| Abl80 Sc80 | 945-706 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Radiometer Medical Aps BROENSHOEJ Hovedstaden · DK FEI 3002807968