FDA Registration
Active
🇲🇾 Malaysia
BERGAMOT SDN BHD
Reg #: 3014743234
·
FEI: 3014743234
·
Expires 2026
Products
3
Proprietary Names
0
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- BERGAMOT SDN BHD
- Registration Number
- 3014743234
- FEI Number
- 3014743234
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO. 7 & 8, JALAN SINARAN 6, KAWASAN PERINDUSTRIAN SINARAN
- City
- KAJANG Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K000999
Owner / Operator
- Firm Name
- BERGAMOT SDN BHD
- Operator Number
- 10079487
- Address
- NO. 7 & 8, JALAN SINARAN 6, KAWASAN PERINDUSTRIAN SINARAN
- City
- KAJANG
- State
- Selangor
- Postal Code
- 43000
- Country
- MY
- Correspondent
- SITI KARTIKA HAMDAN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2020-12-09 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2020-12-09 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-12-29 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)