Surgiceye GmbH
GermanyFDA applicant, unverified
- Devices
- 4
What Surgiceye GmbH makes
Surgiceye GmbH manufactures scintillation radiation measuring probes and associated imaging systems designed for intraoperative use. These include handheld detectors like the declipse®SPECT and the DECLIPSESPECT VIEWER, as well as integrated surgical suites such as the CONFIDENT SURGERY SUITE 300 (CSS300) and laparoscopic variants for precise radiation monitoring during procedures. The devices are intended to enhance safety by providing real-time feedback on radiation exposure during surgical interventions.
The company’s products fall under Class I medical device classification in regulatory frameworks. These devices are listed in the FDA’s 510(k) and UDI registries, adhering to U.S. compliance requirements. The manufacturer operates from the United States, ensuring its products meet applicable domestic regulatory standards.
Catalogue
- Registry: GUDID
Declipsespect Viewer Ref K123917
Regimes: 510(k) Registry: 510(k)Confident Surgery Suite 300, Model CSS300 Ref K101887
Regimes: 510(k) Registry: 510(k)Declipsespect Laparoscopy Ref K133781
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 340279325
- [email protected]
- Phone
- +4989549989050
Frequently asked questions
How many devices does Surgiceye GmbH have in the registry?
The registry currently lists 4 devices for Surgiceye GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgiceye GmbH's devices?
Among its 4 most recently registered devices, Surgiceye GmbH has devices listed in FDA 510(k) (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Surgiceye GmbH's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Surgiceye GmbH's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Surgiceye GmbH in the registry?
The most recently registered devices listed for Surgiceye GmbH include declipse®SPECT declipseSPECT Viewer, DECLIPSESPECT VIEWER, CONFIDENT SURGERY SUITE 300, MODEL CSS300 and DECLIPSESPECT LAPAROSCOPY.