Shokz Health Global Limited
Active in EUDAMEDHong Kong SAR Chinafrom EUDAMED address EUDAMED FDA SRN HK-MF-000049310 FEI 3049809193
- Devices
- 1
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Bone conduction Hearing Aid (BM100) Ref K253431
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- HK-MF-000049310
- FDA FEI number
- 3049809193
- EUDAMED status
- Active
- EUDAMED registered name
- Shokz Health Global Limited
- Address
- ROOM 708, 7TH FLOOR, HANG SENG CASTLE PEAK ROAD BUILDING, KOWLOON
- [email protected]
- PRRC contact
- Qingyu Zeng
Frequently asked questions
How many devices does Shokz Health Global Limited have in the registry?
The registry currently lists 1 device for Shokz Health Global Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shokz Health Global Limited's devices?
Among its 1 most recently registered device, Shokz Health Global Limited has devices listed in FDA 510(k) (1 device).
What risk classes do Shokz Health Global Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Shokz Health Global Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shokz Health Global Limited in the registry?
The most recently registered devices listed for Shokz Health Global Limited include Bone conduction Hearing Aid (BM100).