FDA Registration
Active
🇲🇾 Malaysia
PERUSAHAAN GETAH ASAS SDN BHD
Reg #: 3011198350
·
FEI: 3011198350
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PERUSAHAAN GETAH ASAS SDN BHD
- Registration Number
- 3011198350
- FEI Number
- 3011198350
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot PT 54925, NO 5, JALAN KORPORAT 7C/KU9, TAMAN PERINDUSTRIAN MERU, MUKIM KAPAR
- City
- KLANG Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K031414
Owner / Operator
- Firm Name
- PERUSAHAAN GETAH ASAS SDN BHD
- Operator Number
- 8040956
- Address
- LOT 1365, BATU 17, JALAN SUNGAI SEMBILANG, --
- City
- JERAM
- State
- Selangor
- Postal Code
- 45800
- Country
- MY
US Agent
- Business Name
- Parexel International
- Contact Name
- Sowmya Sony Janampally
- Address
- 2520 Meridian Parkway, Research Triangle Park, Suite 200
- City
- Durham
- State
- NC
- ZIP
- 27713
- Country
- US
- [email protected]
- Phone
- 978 5456290
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2007-11-01 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device