FDA Registration
Active
🇲🇾 Malaysia
Accu-Chek Guide Blood Glucose Monitoring System
Reg #: 3030311186
·
FEI: 3030311186
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Altek Medical Sdn. Bhd.
- Registration Number
- 3030311186
- FEI Number
- 3030311186
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 12, Jalan Teknologi Perintis 1/3, Taman Teknologi Nusajaya,
- City
- Iskandar Puteri Johor
- Country
- MY
Owner / Operator
- Firm Name
- Altek Biotechnology Corporation
- Operator Number
- 10029462
- Address
- 4F, No. 12, Li-Hsin Road,, Science-Based Industrial Park
- City
- Hsinchu
- State
- Hsinchu (City)
- Postal Code
- 300
- 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 | 2023-10-27 |
Proprietary Names
Accu-Chek Guide Blood Glucose Monitoring System
IWLCaretech Blood Glucose Monitoring System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)