Hygieia, Inc.
Country not established
- Devices
- 3
What Hygieia, Inc. makes
Hygieia, Inc. manufactures programmable calculators designed for medical navigation and planning, including the d-Nav® system. These devices support intraoperative guidance and surgical navigation tasks, providing real-time data processing for precision procedures.
The company’s products are regulated as Class II medical devices in the US, with submissions recorded under FDA 510(k) and UDI requirements. The portfolio is listed in the FDA’s regulatory databases, reflecting compliance with US device authorisation standards.
Catalogue
- Registry: GUDID
- Registry: GUDID
d-Nav System Ref K181916
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 073601434
- [email protected]
- Phone
- 8888214497
Frequently asked questions
How many devices does Hygieia, Inc. have in the registry?
The registry currently lists 3 devices for Hygieia, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hygieia, Inc.'s devices?
Among its 3 most recently registered devices, Hygieia, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Hygieia, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Hygieia, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hygieia, Inc. in the registry?
The most recently registered devices listed for Hygieia, Inc. include d-Nav® V1m00b053d, d-Nav® V1m00b054i and d-Nav System.