Seiratherm GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Seiratherm GmbH makes
Seiratherm GmbH manufactures TEMPEDY, a medical device designed for temperature monitoring and management in clinical settings, ensuring precise thermal regulation for patient care.
The TEMPEDY device falls under FDA Class II regulation and is listed via the 510(k) pathway in the United States. The company is based in the US.
Catalogue
Tempedy Ref K152946
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Seiratherm GmbH have in the registry?
The registry currently lists 1 device for Seiratherm GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Seiratherm GmbH's devices?
Among its 1 most recently registered device, Seiratherm GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Seiratherm GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Seiratherm GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Seiratherm GmbH in the registry?
The most recently registered devices listed for Seiratherm GmbH include TEMPEDY.