FDA Registration
Active
🇲🇾 Malaysia
GX Corporation Sdn Bhd (Specialty Plant)
Reg #: 3012441043
·
FEI: 3012441043
·
Expires 2026
Products
5
Proprietary Names
0
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- GX Corporation Sdn Bhd (Specialty Plant)
- Registration Number
- 3012441043
- FEI Number
- 3012441043
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Plot 6497-A, Lorong Haji Abdul Manan, 5 3/4 Milestone, Sementa. Jalan kapar,
- City
- Klang Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K091643
Owner / Operator
- Firm Name
- GX CORPORATION SDN BHD
- Operator Number
- 9095340
- Address
- Lot 6491, Batu 5 3/4 Sementa, Jalan Kapar
- City
- Klang
- State
- Selangor
- Postal Code
- 42100
- Country
- MY
US Agent
- Business Name
- FDA Agent Pro LLC
- Contact Name
- Danny West
- Address
- 1553 Hunters Glen Avenue, Suite 200
- City
- Chula Vista
- State
- CA
- ZIP
- 91913
- Country
- US
- [email protected]
- Phone
- 619 4103883
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2009-11-03 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2008-03-07 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2019-07-18 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-06-30 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2020-06-29 |
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)