Mivenion GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Mivenion GmbH makes
Mivenion GmbH manufactures the XIRALITE Fluorescence Imaging System X4, a Class II medical device designed for fluorescence-based imaging applications in clinical settings.
The XIRALITE Fluorescence Imaging System X4 is regulated under the FDA’s 510(k) pathway and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Xiralite Flourescence Imaging System X4 Ref K130003
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mivenion GmbH have in the registry?
The registry currently lists 1 device for Mivenion GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mivenion GmbH's devices?
Among its 1 most recently registered device, Mivenion GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Mivenion GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Mivenion GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mivenion GmbH in the registry?
The most recently registered devices listed for Mivenion GmbH include XIRALITE FLOURESCENCE IMAGING SYSTEM X4.