Radiometer Basel AG
SwitzerlandFDA applicant, unverified FDA FEI 3002663379
Radiometer Basel AG is a medical device manufacturer, with 18 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.
- Devices
- 18
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 17
- FDA 510(k) 1
- Device classes
- FDA Class II 18
- Identifiers
- FDA FEI 3002663379
- DUNS 481337657
At a glance
Market reach
- United States
- FDA FEI
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.
Catalogue
Search and filter all 18 devicesCompany details
- FDA FEI number
- 3002663379
- DUNS number
- 481337657
- Address
- AUSTRASSE 25, BASEL Basel-Stadt
- Phone
- +459999999999
Frequently asked questions
How many devices does Radiometer Basel AG have in the registry?
The registry currently lists 18 devices for Radiometer Basel AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Radiometer Basel AG's devices?
Among its 18 most recently registered devices, Radiometer Basel AG has devices listed in FDA 510(k) (1 device) and FDA GUDID (17 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Radiometer Basel AG's devices fall under?
Among its 18 most recently registered devices, the classes recorded for Radiometer Basel AG's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Radiometer Basel AG in the registry?
The most recently registered devices listed for Radiometer Basel AG include Application set Neonatal 0607120, Application set 0607110, Calibration Gas 0640210 and Supplies for COMBI *M 82 0605200.