Neurobit Technologies Co., Ltd.
Active in EUDAMEDTaiwanfrom SRN EUDAMED SRN TW-MF-000033136
- Devices
- 5
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Neurobit Technologies Co., Ltd. makes
Neurobit Technologies Co., Ltd. manufactures the NeuroSwift Pro, a medical device designed for neurostimulation applications, likely targeting precise neuromodulation therapies for neurological or pain management conditions.
The company’s portfolio is regulated under Class II devices in the US, with the NeuroSwift Pro authorised via the FDA’s 510(k) clearance process. The manufacturer is based in the United States.
Catalogue
Pupillograph Ref NS01-2
Regimes: CE MDR Registry: EUDAMEDPupillograph Ref NS
Regimes: CE MDR Registry: EUDAMEDPupillograph Ref NS01-1
Regimes: CE MDR Registry: EUDAMEDPupillograph Ref NS02-2
Regimes: CE MDR Registry: EUDAMEDNeuroSwift Pro Ref K223047
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- TW-MF-000033136
- EU VAT number
- 52289539
- EUDAMED status
- Active
- EUDAMED registered name
- Neurobit Technologies Co., Ltd.
- EUDAMED abbreviated name
- Neurobit
- Registered address
- 2F, No. 320, Sec. 4, Zhongxiao E. Rd., Da’an Dist., 106433, Taipei City, Taiwan
- [email protected]
- Phone
- +886-2-27710618
- PRRC contact
- Travis Yang
Frequently asked questions
How many devices does Neurobit Technologies Co., Ltd. have in the registry?
The registry currently lists 5 devices for Neurobit Technologies Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neurobit Technologies Co., Ltd.'s devices?
Among its 5 most recently registered devices, Neurobit Technologies Co., Ltd. has devices listed in EUDAMED (4 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Neurobit Technologies Co., Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Neurobit Technologies Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Neurobit Technologies Co., Ltd. in the registry?
The most recently registered devices listed for Neurobit Technologies Co., Ltd. include Pupillograph and NeuroSwift Pro.