FDA Registration
Active
🇻🇳 Vietnam
Omron Healthcare Manufacturing Vietnam Co., Ltd.
Reg #: 3006852037
·
FEI: 3006852037
·
Expires 2026
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Omron Healthcare Manufacturing Vietnam Co., Ltd.
- Registration Number
- 3006852037
- FEI Number
- 3006852037
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 28 VSIP II, Street No. 2, Vietnam-Singapore Industrial Park II, Binh Duong Ward
- City
- Ho Chi Minh City
- Country
- VN
Owner / Operator
- Firm Name
- OMRON HEALTHCARE MANUFACTURING VIETNAM Co., Ltd.
- Operator Number
- 10023852
- Address
- No. 28 VSIP II, Street No. 2, Vietnam-Singapore Industrial Park II, Binh Duong Ward
- City
- Ho Chi Minh City
- State
- VN-SG
- Postal Code
- 70000
- Country
- VN
- Correspondent
- Thu Nguyen Minh
US Agent
- Business Name
- OMRON HEALTHCARE, INC.
- Contact Name
- Terri Ingalls
- Address
- 2895 Greenspoint Parkway, Suite 100
- City
- Hoffman Estates
- State
- IL
- ZIP
- 60169
- Country
- US
- [email protected]
- Phone
- 847 2475657
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-03-14 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2016-06-09 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2022-04-11 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2022-04-11 |
| Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature | QXY | Class 2 | Cardiovascular | No | 2024-12-02 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)