FDA Registration
Active
🇲🇾 Malaysia
HARTALEGA NGC SDN. BHD. (LOT 39496)
Reg #: 3019769825
·
FEI: 3019769825
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- HARTALEGA NGC SDN. BHD. (LOT 39496)
- Registration Number
- 3019769825
- FEI Number
- 3019769825
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.2 (Lot 39496), Persiaran Tanjung, Kawasan Perindustrian Tanjung, Jalan B20,
- City
- Sepang Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K243818
Owner / Operator
- Firm Name
- Hartalega NGC Sdn. Bhd. (Lot 39496)
- Operator Number
- 10090827
- Address
- No.2 (Lot 39496), Persiaran Tanjung, Kawasan Perindustrian Tanjung, Jalan B20,
- City
- Sepang
- State
- Selangor
- Postal Code
- 43900
- Country
- MY
- Correspondent
- Eu Jin Kuan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-01-12 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-01-12 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-01-12 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-01-12 |
Establishment Types
Manufacture Medical Device