FDA Registration
Active
🇲🇾 Malaysia
SENTIENX SDN BHD
Reg #: 3011580969
·
FEI: 3011580969
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SENTIENX SDN BHD
- Registration Number
- 3011580969
- FEI Number
- 3011580969
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot 7, Jalan Hi-Tech 12, Zon Industri Fasa 3, Kulim Hi-Tech Park
- City
- Kulim Kedah
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K153510
Owner / Operator
- Firm Name
- Sentienx Sdn Bhd
- Operator Number
- 10049922
- Address
- Lot 7, Jalan Hi-Tech 12, Zon Industri Fasa 3, Kulim Hi-Tech Park
- City
- KULIM
- State
- Kedah
- Postal Code
- 09090
- Country
- MY
- Correspondent
- Ng Yong Lin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2018-10-15 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)