FDA Registration
Active
🇻🇳 Vietnam
Trima Accel Platelet + Sampler, Plasma, RBC Set (ISBT)
Reg #: 3011720361
·
FEI: 3011720361
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Terumo BCT Vietnam Co., Ltd.
- Registration Number
- 3011720361
- FEI Number
- 3011720361
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Long Duc Industrial Park, Long Duc Commune
- City
- Long Thanh District Dong Nai
- Country
- VN
Regulatory Submissions
- 510(k) Number
- BK040069
Owner / Operator
- Firm Name
- Terumo BCT, INC.
- Operator Number
- 9002708
- Address
- 10811 WEST COLLINS AVE., --
- City
- Lakewood
- State
- CO
- Postal Code
- 80215
- Country
- US
- Correspondent
- Corrine Lucas
US Agent
- Business Name
- Terumo BCT, Inc.
- Contact Name
- Corrine Lucas
- Address
- 10811 W Collins Ave
- City
- Lakewood
- State
- CO
- ZIP
- 80215
- Country
- US
- [email protected]
- Phone
- 720 6106034
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Separator, Automated, Blood Cell, Diagnostic | GKT | Class 2 | Hematology | No | 2016-08-18 |
Proprietary Names
Trima Accel Platelet + Sampler, Plasma, RBC Set (ISBT)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)