TaiHao Medical Inc.
Active in EUDAMEDTaiwanfrom SRN EUDAMED SRN TW-MF-000026480
- Devices
- 6
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What TaiHao Medical Inc. makes
Taihao Medical, Inc. manufactures navigation and visualization software tools for bronchoscopy procedures, including systems for airway mapping (BU-CAD) and real-time imaging guidance (BR-FHUS Navigation and Viewer). Their portfolio also includes software for analyzing virtual bronchoscopy scans (BR-ABVS Viewer).
These devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance pathway. The company is based in the United States.
Catalogue
- Regimes: CE MDR Registry: EUDAMED
- Regimes: CE MDR Registry: EUDAMED
Bu-Cad Ref K210670
Regimes: 510(k) Registry: 510(k)BR-FHUS Navigation 1.0 Ref K171309
Regimes: 510(k) Registry: 510(k)BR-FHUS Viewer 1.0 Ref K171709
Regimes: 510(k) Registry: 510(k)BR-ABVS Viewer 1.0 Ref K151075
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- TW-MF-000026480
- EU VAT number
- 54367428
- EUDAMED status
- Active
- EUDAMED registered name
- TaiHao Medical Inc.
- EUDAMED abbreviated name
- TaiHao
- Registered address
- 6F.-1, No.100, Sec. 2, Heping E. Rd., Da’an Dist., 10663, Taipei City, Taiwan
- [email protected]
- Phone
- +886-2-27365679
- PRRC contact
- Rong Tai Chen
Frequently asked questions
How many devices does TaiHao Medical Inc. have in the registry?
The registry currently lists 6 devices for TaiHao Medical Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list TaiHao Medical Inc.'s devices?
Among its 6 most recently registered devices, TaiHao Medical Inc. has devices listed in EUDAMED (2 devices) and FDA 510(k) (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do TaiHao Medical Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for TaiHao Medical Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from TaiHao Medical Inc. in the registry?
The most recently registered devices listed for TaiHao Medical Inc. include BR-FHUS Smart System, BR-Viewer, BU-CAD and BR-FHUS Navigation 1.0.