FDA Registration
Active
🇹🇼 Taiwan
NMax Plus Glucose/Ketone Meter
Reg #: 9710595
·
FEI: 3003400058
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- GLOBAL INSTRUMENTATION CORP.
- Registration Number
- 9710595
- FEI Number
- 3003400058
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14 F., NO. 186, JIAN-YI ROAD, CHUNG-HO DISTRICT
- City
- NEW TAIPEI
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K091547
Owner / Operator
- Firm Name
- GLOBAL INSTRUMENTATION CORP.
- Operator Number
- 9046757
- Address
- 14 F., NO. 186, JIAN-YI ROAD, CHUNG-HO
- City
- NEW TAIPEI
- State
- TW-NOTA
- Postal Code
- 235
- Country
- TW
- Correspondent
- BO-YI - CHEN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2013-01-23 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2013-01-23 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-01-23 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2013-01-23 |
Proprietary Names
NMax Plus Glucose/Ketone Meter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)