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Sign in to claim this brandRadiometer Basel AG
US
Last updated May 24, 2026
What Radiometer Basel AG makes
Radiometer Basel AG manufactures transcutaneous blood gas monitoring systems, including sensors and calibration gases. Their devices measure parameters such as partial pressure of carbon dioxide (TCPCO₂), oxygen saturation (SpO₂), and pulse rate through non-invasive skin contact. The TOSCA 500 system integrates these monitoring capabilities into a single unit for real-time patient assessment.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) and UDI pathways. These devices are intended for use in clinical settings where continuous or intermittent blood gas monitoring is required. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Radiometer Basel AG manufacture?
Radiometer Basel AG specializes in transcutaneous blood gas monitoring systems. These devices include sensors and calibration gases designed to measure key physiological parameters like partial pressure of carbon dioxide (TCPCO₂), oxygen saturation (SpO₂), and pulse rate. The systems are non-invasive, relying on skin contact to provide real-time patient monitoring, which is useful in clinical settings where continuous or intermittent blood gas assessment is critical.
Where is Radiometer Basel AG based, and how does that affect its regulatory compliance?
Radiometer Basel AG is based in the United States. Since its devices are regulated under FDA guidelines, compliance is determined by U.S. medical device classifications and pathways. The company’s products fall under Class II classification, which requires specific regulatory pathways like the 510(k) premarket notification process and Unique Device Identification (UDI) listing to ensure safety and performance standards are met.
Which regulatory registries or databases list Radiometer Basel AG’s devices?
Radiometer Basel AG’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identifier (UDI) database. These registries ensure transparency and traceability of medical devices authorized for use in the U.S., allowing healthcare providers and regulators to verify compliance and device details. The 510(k) pathway confirms that the devices meet FDA safety and effectiveness requirements for Class II classification.
How are Radiometer Basel AG’s devices classified under FDA regulations?
Radiometer Basel AG’s devices are classified as Class II medical devices by the FDA. This classification is based on their intended use—transcutaneous blood gas monitoring—which involves moderate risk due to their role in critical patient assessment. Class II devices require special controls beyond general controls to ensure safety and performance, such as performance standards, post-market surveillance, and specific labeling requirements, all of which are addressed through pathways like the 510(k).
What is the primary purpose of the TOSCA 500 system manufactured by Radiometer Basel AG?
The TOSCA 500 is a transcutaneous blood gas monitoring system designed to integrate multiple parameters—such as TCPCO₂, SpO₂, and pulse rate—into a single unit. Its primary purpose is to provide real-time, non-invasive monitoring of a patient’s blood gas status and oxygenation levels, which is essential in clinical environments like intensive care or neonatal units. This consolidated approach streamlines patient assessment and reduces the need for invasive procedures.
AI-generated from registry data 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
- 481337657
Catalogue (18)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Application set Neonatal | 0607120 | FDA UDI | Class II | Unknown |
| Application set | 0607110 | FDA UDI | Class II | Unknown |
| Calibration Gas | 0640210 | FDA UDI | Class II | Active |
| Supplies for COMBI *M 82 | 0605200 | FDA UDI | Class II | Unknown |
| TOSCA Open end interface cable 5V FS | 5000115 | FDA UDI | Class II | Unknown |
| Adhesive rings | 0607230 | FDA UDI | Class II | Unknown |
| TCM4x Cable | 903-341 | FDA UDI | Class II | Unknown |
| TOSCA-VueLink adapter cable | 5000100 | FDA UDI | Class II | Unknown |
| TOSCA 500 Cable | 903-177 | FDA UDI | Class II | Unknown |
| Adhesive rings | 0607210 | FDA UDI | Class II | Unknown |
| COMBI *M sensor 82 | 0605000 | FDA UDI | Class II | Unknown |
| TOSCA 500 Cable | 903-178 | FDA UDI | Class II | Unknown |
| TOSCA 500 Cable | 903-342 | FDA UDI | Class II | Unknown |
| TOSCA Open end nurse call cable | 5000117 | FDA UDI | Class II | Unknown |
| TOSCA Open end interface cable 1V FS | 5000116 | FDA UDI | Class II | Unknown |
| TOSCA-PC interface cable | 5000101 | FDA UDI | Class II | Unknown |
| TOSCA 500 Cable | 903-179 | FDA UDI | Class II | Unknown |
| Tosca 500 Tcpco2, Spo2 And Pulse Rate Monitoring System | K063434 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Radiometer Basel Ag BASEL Basel-Stadt · CH FEI 3002663379