FDA Registration
Active
🇲🇾 Malaysia
EASYMED INSTRUMENTS SE ASIA SDN. BHD.
Reg #: 3027241812
·
FEI: 3027241812
·
Expires 2026
Products
5
Proprietary Names
2
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- EASYMED INSTRUMENTS SE ASIA SDN. BHD.
- Registration Number
- 3027241812
- FEI Number
- 3027241812
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18-01 & 18-02, Jalan Permas 9/16, Bandar Baru Permas Jaya
- City
- Masai Johor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K140168
Owner / Operator
- Firm Name
- Easymed Instruments SE Asia Sdn. Bhd.
- Operator Number
- 10087827
- Address
- 18-01 & 18-02, Jalan Permas 9/16, Bandar Baru Permas Jaya
- City
- Masai
- State
- Johor
- Postal Code
- 81750
- Country
- MY
- Correspondent
- Liyun Li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2026-02-06 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2026-02-06 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2026-02-06 |
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2026-02-06 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2024-12-19 |
Proprietary Names
AMPCARE ESP Therapy System
Ampcare ES
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device