FDA Registration
Active
🇲🇾 Malaysia
RIVERSTONE RESOURCES SDN. BHD.
Reg #: 9617453
·
FEI: 3003158169
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- RIVERSTONE RESOURCES SDN. BHD.
- Registration Number
- 9617453
- FEI Number
- 3003158169
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT 55, NO. 13, JALAN JASMIN 2, Kawasan Perindustrian, Bukit Beruntung
- City
- BUKIT BERUNTUNG, Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K112924
Owner / Operator
- Firm Name
- RIVERSTONE RESOURCES SDN. BHD.
- Operator Number
- 8040854
- Address
- LOT 55, NO. 13 JALAN JASMIN 2, Kawasan Perindustrian
- City
- Bukit Beruntung
- State
- Selangor
- Postal Code
- 48300
- 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 |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2017-03-29 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2017-03-29 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-01-04 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-01-04 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2015-04-16 |
Proprietary Names
Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim
Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
White Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim
Get-A-Grip
Halyard Purple Nitrile Max Powder -Free Exam Glove for use with Chemotherapy Drugs
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device