FDA Registration
Active
🇲🇾 Malaysia
BRIGHTWAY HOLDINGS SDN. BHD.
Reg #: 9617444
·
FEI: 1000153304
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- BRIGHTWAY HOLDINGS SDN. BHD.
- Registration Number
- 9617444
- FEI Number
- 1000153304
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT 1559, JALAN ISTIMEWA,, BATU BELAH
- City
- KLANG, Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K170686
Owner / Operator
- Firm Name
- BRIGHTWAY HOLDINGS SDN. BHD.
- Operator Number
- 9036471
- Address
- LOT 1559, JALAN ISTIMEWA,, BATU BELAH
- City
- KLANG, SELANGOR
- State
- MY-NOTA
- Postal Code
- 42100
- Country
- MY
- Correspondent
- BASKARAN - GOVINDASAMY
US Agent
- Business Name
- FDABasics LLC
- Contact Name
- Jerry Doane Doane
- Address
- 15815 SW 11th Court Rd., Ocala, Florida 34473
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2019-03-26 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2019-03-26 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2007-12-14 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2007-12-14 |
Proprietary Names
BRIGHTWAY BRAND
CTI International
Diamond M Latex Examination Powder Free Gloves
SMC BLUE
Establishment Types
Manufacture Medical Device