FDA Registration
Active
🇹🇼 Taiwan
Rightest GM250 Blood Glucose Monitoring System
Reg #: 3004183148
·
FEI: 3004183148
·
Expires 2025
Products
3
Proprietary Names
7
Establishment Types
1
Classifications
3
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
- K092052
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 |
|---|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2010-06-21 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2010-06-21 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2010-06-21 |
Proprietary Names
Rightest GM250 Blood Glucose Monitoring System
McKesson Quintet AC Blood Glucose Test Strip
McKesson Quintet AC Blood Glucose Monitoring System
Rightest Blood Glucose Monitoring System, Model GM550
GE GE100 Blood Glucose Monitoring System
McKesson Quintet AC Control Solution
Rightest Control Solution GC550
Establishment Types
Manufacture Medical Device