FDA Registration
Active
🇹🇼 Taiwan
Rightest Blood Glucose Monitoring System Max Plus
Reg #: 3004183148
·
FEI: 3004183148
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BIONIME CORPORATION
- Registration Number
- 3004183148
- FEI Number
- 3004183148
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO. 100, Sec. 2, Daqing St., South Dist.
- City
- Taichung City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K173638
Owner / Operator
- Firm Name
- BIONIME CORPORATION
- Operator Number
- 9059262
- Address
- NO. 100, Sec. 2, Daqing St., SOUTH DIST.
- City
- TAICHUNG CITY
- State
- TW-NOTA
- Postal Code
- 40242
- Country
- TW
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2018-09-04 |
Proprietary Names
Rightest Blood Glucose Monitoring System Max Plus
Rightest Blood Glucose Monitoring System Max
GE Blood Glucose Monitoring System Max
GE Blood Glucose Monitoring System Max Plus
GE Blood Glucose Test Strip Max
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device