FDA Registration
Active
🇻🇳 Vietnam
TREO Abdominal Stent-Graft System
Reg #: 3016521833
·
FEI: 3016521833
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TERUMO VIETNAM CO., LTD
- Registration Number
- 3016521833
- FEI Number
- 3016521833
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot 44A-44B-44C, Quang Minh Industrial Zone, Chi Dong Town, Me Linh District
- City
- Hanoi City Ha Noi
- Country
- VN
Regulatory Submissions
- PMA Number
- P190015
Owner / Operator
- Firm Name
- Terumo Vietnam Co., Ltd
- Operator Number
- 10090035
- Address
- Lot 44A-44B-44C, Quang Minh Industrial Zone, Chi Dong Town, Me Linh District
- City
- Hanoi City
- State
- Ha Noi
- Postal Code
- 100000
- Country
- VN
- Correspondent
- Ly Dang
US Agent
- Business Name
- Bolton Medical, Inc
- Contact Name
- Megan Indeglia
- Address
- 799 International Parkway
- City
- Sunrise
- State
- FL
- ZIP
- 33325
- Country
- US
- [email protected]
- Phone
- 754 6633748
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | Class 3 | Unknown | No | 2024-02-06 |
Proprietary Names
TREO Abdominal Stent-Graft System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)