FDA Registration
Active
🇲🇾 Malaysia
IDEAL QUALITY SDN BHD
Reg #: 3015335034
·
FEI: 3015335034
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- IDEAL QUALITY SDN BHD
- Registration Number
- 3015335034
- FEI Number
- 3015335034
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LOT 6103, JALAN HAJI ABDUL MANAN / KU 8, KAWASAN PERINDUSTRIAN MERU SELATAN,
- City
- KLANG Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K232461
Owner / Operator
- Firm Name
- IDEAL QUALITY SDN BHD
- Operator Number
- 10030536
- Address
- LOT 6075, JALAN HAJI ABDUL MANAN / KU8, KAWASAN PERINDUSTRIAN MERU BARAT
- City
- KLANG
- State
- Selangor
- Postal Code
- 41050
- Country
- MY
- Correspondent
- KUANG YONG LIM
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 |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-12-11 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-12-11 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-12-11 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-12-11 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)