FDA Registration
Active
🇹🇼 Taiwan
HUKUI BIOTECHNOLOGY CO., LTD.
Reg #: 3016842138
·
FEI: 3016842138
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- HUKUI BIOTECHNOLOGY CO., LTD.
- Registration Number
- 3016842138
- FEI Number
- 3016842138
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8F-1 & 2, No.1, Huanke 1st Rd.
- City
- Zhubei City Hsinchu
- Country
- TW
Owner / Operator
- Firm Name
- Hukui Biotechnology Co., Ltd.
- Operator Number
- 10090863
- Address
- 11F-1, No. 2, Sec. 3, Bade Rd.
- City
- Taipei City
- State
- TW-TPE
- Postal Code
- 105608
- Country
- TW
- Correspondent
- Amy Tsai
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2026-05-12 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2026-05-12 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2026-05-12 |
| Camera, Still, Endoscopic | FXM | Class 1 | General, Plastic Surgery | No | 2024-05-24 |
Proprietary Names
ASUS Ultrasound Imaging System (LU800 series)
LELTEK Ultrasound Imaging System
Camera, Still, Endoscopic
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device