Nuvo- Group, Ltd.
IsraelFDA applicant, unverified
- Devices
- 3
What Nuvo- Group, Ltd. makes
Nuvo-Group, Ltd. manufactures pregnancy testing devices, including the INVU by Nuvo and PregSense, which detect hCG levels for early pregnancy confirmation. These products are designed for home use and provide rapid results.
The company’s portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) clearance process. These devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
INVU by Nuvo Ref K210025
Regimes: 510(k) Registry: 510(k)PregSense Ref K191401
Regimes: 510(k) Registry: 510(k)Invu by Nuvo Ref K221046
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nuvo- Group, Ltd. have in the registry?
The registry currently lists 3 devices for Nuvo- Group, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nuvo- Group, Ltd.'s devices?
Among its 3 most recently registered devices, Nuvo- Group, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Nuvo- Group, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Nuvo- Group, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nuvo- Group, Ltd. in the registry?
The most recently registered devices listed for Nuvo- Group, Ltd. include INVU by Nuvo and PregSense.