FDA Registration
Active
🇲🇾 Malaysia
ECO MEDI GLOVE SDN BHD
Reg #: 3021591319
·
FEI: 3021591319
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ECO MEDI GLOVE SDN BHD
- Registration Number
- 3021591319
- FEI Number
- 3021591319
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Pt 33500,Jalan Perusahaan 1, Kawasan Perusahaan Kamunting
- City
- Taiping Perak
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K233560
Owner / Operator
- Firm Name
- Eco Medi Glove Sdn Bhd
- Operator Number
- 10084216
- Address
- Pt 33500,Jalan Perusahaan 1, Kawasan Perusahaan Kamunting
- City
- Taiping
- State
- Perak
- Postal Code
- 34600
- 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 Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-05-29 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-05-29 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-05-29 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-05-29 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)