Starmedtec GmbH
GermanyFDA applicant, unverified
- Devices
- 7
What Starmedtec GmbH makes
Starmedtec GmbH manufactures Class II medical devices, including the AURIGA XL and AURIGA QI systems, which appear to be imaging or diagnostic devices, as well as the VELA XL, likely a related or complementary device for similar applications. These products are designed for specialized medical use, potentially in radiology or interventional procedures.
The company’s portfolio is regulated under the FDA’s 510(k) pathway, with devices classified as Class II. These products are listed in the FDA’s 510(k) clearance registry, indicating compliance with U.S. regulatory requirements. The manufacturer is based in the United States.
Catalogue
Company details
- DUNS number
- 506964365
Frequently asked questions
How many devices does Starmedtec GmbH have in the registry?
The registry currently lists 7 devices for Starmedtec GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Starmedtec GmbH's devices?
Among its 7 most recently registered devices, Starmedtec GmbH has devices listed in FDA 510(k) (3 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Starmedtec GmbH's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Starmedtec GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Starmedtec GmbH in the registry?
The most recently registered devices listed for Starmedtec GmbH include NA M006864640, NA M006864520, NA M006864500 and NA M006864540.