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 7 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tcm Tosca Monitoring System, Tcm Combim Monitoring System | K093154 | FDA 510(k) | Class II | Active |
| Abl800 Flex | K041874 | FDA 510(k) | Class II | Active |
| Autocheck6+ | K051928 | FDA 510(k) | Class I | Active |
| Aqt90 Flex Ckmb Test Kit, Aqt90 Flex Lqc Multi-Check, Levels 1-3, Aqt90 Flex Ckmb Cal Cartridge | K120326 | FDA 510(k) | Class II | Active |
| Abl837 Flex Analyzer | K100777 | FDA 510(k) | Class II | Active |
| Abl90 Flex | K130144 | FDA 510(k) | Class II | Active |
| Abl90 Flex | K123748 | FDA 510(k) | Class II | Active |
| Abl90 Flex | K120197 | FDA 510(k) | Class II | Active |
| Abl8x7 Flex | K051968 | FDA 510(k) | Class II | Active |
| Abl-700 Series, Model Abl 7xx (various Models) | K002290 | FDA 510(k) | Class II | Active |
| Abl90 | K111897 | FDA 510(k) | Class II | Active |
| ABL90 FLEX PLUS System | K241037 | FDA 510(k) | Class II | Active |
| AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX | K163462 | FDA 510(k) | Class II | Active |
| ABL90 FLEX PLUS System | K240998 | FDA 510(k) | Class II | Active |
| Abl90 Flex, Abl90 Flex Plus | K170882 | FDA 510(k) | Class I | Active |
| ABL90 FLEX PLUS System | K252475 | FDA 510(k) | Class II | Active |
| Safepico | K043143 | FDA 510(k) | Class II | Active |
| Abl90 Flex Analyzer | K131988 | FDA 510(k) | Class II | Active |
| Abl90 Flex Series | K092686 | FDA 510(k) | 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