Navbit Pty Ltd
Active in EUDAMEDAustraliafrom SRN EUDAMED FDA SRN AU-MF-000016920 FEI 3016075969
- Devices
- 6
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Emergo Europe B.V.NL
What Navbit Pty Ltd makes
Navbit Pty Ltd manufactures systems and surgical planning tools for spinal and orthopedic procedures, including supine and lateral registration kits for patient positioning and pre-surgical planning software. Their offerings include the Navbit Sprint System, designed for intraoperative imaging and registration, as well as the Navbit Rapid Surgical Plan for procedural planning.
The company’s devices are classified under EU Class II and Class IIa, with listings in the EUDAMED registry and FDA’s 510(k) database. The manufacturer is based in Australia.
Catalogue
Navbit MARQ Lateral Ref PRD-001-LAT
CE MDR EUDAMEDNavbit MARQ Supine Ref PRD-001-SUP
CE MDR EUDAMED- CE MDD 510(k) 510(k)
Navbit Sprint Ref HBS-00-001
CE MDD, withdrawn EUDAMEDGUDIDNavbit Sprint Ref HBS-00-002
CE MDD, withdrawn EUDAMEDGUDIDNavbit Rapid Surgical Plan Ref RSP-SW-001
CE MDR 510(k) EUDAMED
Company details
- EUDAMED SRN
- AU-MF-000016920
- FDA FEI number
- 3016075969
- DUNS number
- 744162019
- EUDAMED status
- Active
- EUDAMED registered name
- Navbit Pty Ltd
- Registered address
- 4 Cornwallis Street, Suite 201, National Innovation Centre, 2015, Sydney, Australia
- Website
- www.navbit.com
- [email protected]
- Phone
- +61 2 9209 4130
- PRRC contact
- Suganthi Govindaraju
Frequently asked questions
How many devices does NAVBIT PTY LTD have in the registry?
The registry currently lists 6 devices for NAVBIT PTY LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list NAVBIT PTY LTD's devices?
Among its 6 most recently registered devices, NAVBIT PTY LTD has devices listed in EUDAMED (5 devices), 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 NAVBIT PTY LTD's devices fall under?
Among its 6 most recently registered devices, the classes recorded for NAVBIT PTY LTD's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from NAVBIT PTY LTD in the registry?
The most recently registered devices listed for NAVBIT PTY LTD include Navbit MARQ Lateral, Navbit MARQ Supine, Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration and Navbit Sprint.