Heraeus Med GmbH
GermanyFDA applicant, unverified
- Devices
- 3
What Heraeus Med GmbH makes
Heraeus Med GmbH manufactures HANAULUX BLUE series devices, including the HANAULUX BLUE 30, 75, 80, 80 Hospital, and 120 models, which are designed for medical lighting applications in surgical and procedural environments.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Hanaulux Blue 30 & 80 Ref K954169
Regimes: 510(k) Registry: 510(k)Hanaulux Blue 80 Hospital Ref K970886
Regimes: 510(k) Registry: 510(k)Hanaulux Blue 75 And Hanaulux Blue 120 Ref K973466
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Heraeus Med GmbH have in the registry?
The registry currently lists 3 devices for Heraeus Med GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heraeus Med GmbH's devices?
Among its 3 most recently registered devices, Heraeus Med GmbH has devices listed in FDA 510(k) (3 devices).
What risk classes do Heraeus Med GmbH's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Heraeus Med GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Heraeus Med GmbH in the registry?
The most recently registered devices listed for Heraeus Med GmbH include HANAULUX BLUE 30 & 80, HANAULUX BLUE 80 HOSPITAL and HANAULUX BLUE 75 AND HANAULUX BLUE 120.