FDA Registration
Active
🇲🇾 Malaysia
ESP
Reg #: 3010263795
·
FEI: 3010263795
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MEDICAL-LATEX (DUA) SDN BHD
- Registration Number
- 3010263795
- FEI Number
- 3010263795
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plo 8 Senai Industrial Estate, Senai
- City
- Johor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K120555
Owner / Operator
- Firm Name
- Medical-Latex (DUA) SDN BHD
- Operator Number
- 10044547
- Address
- Plo 8 Senai Industrial Estate, Senai
- City
- Johor
- State
- MY-01
- Postal Code
- 81400
- Country
- MY
- Correspondent
- Khairunnisa Warsito
US Agent
- Business Name
- Global Protection Corp.
- Contact Name
- Davin Wedel
- Address
- 12 Channel Street
- City
- Boston
- State
- MA
- ZIP
- 02210
- Country
- US
- [email protected]
- Phone
- 617 9462800
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2013-06-26 |
Proprietary Names
ESP
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device