Ilumark GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Ilumark GmbH makes
Ilumark GmbH manufactures reflective marker spheres and navigation markers designed for visibility and spatial orientation in medical and surgical environments. These devices are intended to enhance procedural precision by providing clear, high-contrast indicators for anatomical landmarks or instrument positioning.
The company’s products fall under Class II regulatory classification in the U.S., requiring premarket notification (510(k)) clearance through the FDA. The portfolio is listed in the FDA’s 510(k) database, adhering to U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Navigation Marker, Reflective Marker Spheres Ref K103192
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ilumark GmbH have in the registry?
The registry currently lists 1 device for Ilumark GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ilumark GmbH's devices?
Among its 1 most recently registered device, Ilumark GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Ilumark GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ilumark GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ilumark GmbH in the registry?
The most recently registered devices listed for Ilumark GmbH include NAVIGATION MARKER, REFLECTIVE MARKER SPHERES.