Sphere Medical, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 1
What Sphere Medical, Ltd. makes
Sphere Medical, Ltd. manufactures in vitro diagnostic devices, including the IVD-GE02, which appears to be a diagnostic test or assay for medical use.
The company’s portfolio is regulated under Class II devices in the U.S. and listed via FDA 510(k) clearance. The manufacturer is based in the United States.
Catalogue
Ivd-GE02 Ref K101947
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sphere Medical, Ltd. have in the registry?
The registry currently lists 1 device for Sphere Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sphere Medical, Ltd.'s devices?
Among its 1 most recently registered device, Sphere Medical, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Sphere Medical, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sphere Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sphere Medical, Ltd. in the registry?
The most recently registered devices listed for Sphere Medical, Ltd. include IVD-GE02.