FDA Registration
Active
🇲🇾 Malaysia
KSG MEDICARE SDN BHD
Reg #: 3022407383
·
FEI: 3022407383
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- KSG MEDICARE SDN BHD
- Registration Number
- 3022407383
- FEI Number
- 3022407383
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PTD 16063 (Lot 15295) Kawasan Perindustrian Tangkak
- City
- Tangkak Johor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K241745
Owner / Operator
- Firm Name
- KSG Medicare Sdn Bhd
- Operator Number
- 10084829
- Address
- PTD 16063 (Lot 15295) Kawasan Perindustrian Tangkak
- City
- Tangkak
- State
- Johor
- Postal Code
- 84900
- Country
- MY
- Correspondent
- Jennifer Yeo
US Agent
- Business Name
- T. Cunningham Consulting & Associates, LLC
- Contact Name
- TERRELL CUNNINGHAM
- Address
- 12812 Meadowbrook Ln
- City
- Waldorf
- State
- MD
- ZIP
- 20601
- Country
- US
- [email protected]
- Phone
- 301 5359600
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-10-25 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-10-25 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-10-25 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-10-25 |
Proprietary Names
Polymer patient examination glove Patient examination glove, specialty Medical gloves with chemotherapy labeling claims
Powder Free Nitrile Examination Glove, Non-sterile (Blue)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)