FDA Registration
Active
🇹🇼 Taiwan
HIVOX
Reg #: 9611558
·
FEI: 3003255512
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HIVOX BIOTEK INC.
- Registration Number
- 9611558
- FEI Number
- 3003255512
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5 F., NO. 123, Xingde Road, Sanchong District
- City
- New Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K232675
Owner / Operator
- Firm Name
- HIVOX BIOTEK, INC.
- Operator Number
- 9044329
- Address
- 5 F., NO. 123, Xingde Road, Sanchong District
- City
- New Taipei City
- State
- TW-NOTA
- Postal Code
- 24158
- Country
- TW
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2024-02-09 |
Proprietary Names
HIVOX
Establishment Types
Manufacture Medical Device