FDA Registration
Active
🇹🇼 Taiwan
Tyson Bio HS100 Blood Glucose Monitoring System
Reg #: 3003132490
·
FEI: 3003132490
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TYSON BIORESEARCH, INC.
- Registration Number
- 3003132490
- FEI Number
- 3003132490
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5F., No. 16, 18, 20, 22, Kedong 3rd Rd.
- City
- Zhunan Township Miaoli
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K182046
Owner / Operator
- Firm Name
- TYSON BIORESEARCH, INC.
- Operator Number
- 9047348
- Address
- 5F., No. 16, 18, 20, 22, Kedong 3rd Rd.,
- City
- Zhunan Township, Miaoli County
- State
- TW-NOTA
- Postal Code
- 35053
- Country
- TW
- Correspondent
- Roger - Lee
US Agent
- Business Name
- mdi Consultants, Inc.
- Contact Name
- Diane Furnari
- Address
- 55 Northern Blvd., Great Neck,
- City
- Allenwood
- State
- NY
- ZIP
- 11021
- Country
- US
- [email protected]
- Phone
- 516 4829001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2019-01-02 |
Proprietary Names
Tyson Bio HS100 Blood Glucose Monitoring System
Tyson Bio HS100-B Blood Glucose Monitoring System
Tyson Bio HS200-B Blood Glucose Monitoring System
Tyson Bio HS200 Blood Glucose Monitoring System
Genteel HS100 Blood Glucose Monitoring System
GLUCO-CARE HS100 Blood Glucose Monitoring System
Establishment Types
Manufacture Medical Device