FDA Registration
Active
🇹🇼 Taiwan
GE Blood Glucose Monitoring System 180
Reg #: 3004183148
·
FEI: 3004183148
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
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
- K170143
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 | 2017-07-09 |
Proprietary Names
GE Blood Glucose Monitoring System 180
Rightest Blood Glucose Monitoring System GM280B
Rightest Blood Glucose Monitoring System GM280
GE Blood Glucose Monitoring System 182
Diathrive+ Bluetooth Blood Glucose Monitoring System
Diathrive+ Blood Glucose Monitoring System
GE GlucoCapture Cielo Blood Glucose Monitoring System
GE GlucoCapture Cielo Plus Blood Glucose Monitoring System
Diathrive Blood Glucose Test Strip
Establishment Types
Manufacture Medical Device