FDA Registration
Active
🇲🇾 Malaysia
RUBBEREX ALLIANCE SDN. BHD.
Reg #: 3003011227
·
FEI: 3003011227
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- RUBBEREX ALLIANCE SDN. BHD.
- Registration Number
- 3003011227
- FEI Number
- 3003011227
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot 138201 off 3/4 mile, Jalan Bercham, Kawasan Perindustrian Bercham
- City
- Ipoh Perak
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K210990
Owner / Operator
- Firm Name
- Rubberex Alliance Sdn. Bhd.
- Operator Number
- 10051501
- Address
- Lot 138201 off 3/4 mile, Jalan Bercham, Kawasan Perindustrian Bercham
- City
- Ipoh
- State
- Perak
- Postal Code
- 31400
- Country
- MY
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2021-12-10 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Repack or Relabel Medical Device