FDA Registration
Active
🇺🇸 United States
Terumo2207 (PT) - Rika Plasma Bottle
Reg #: 3012102437
·
FEI: 3012102437
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Synergy Health AST, LLC
- Registration Number
- 3012102437
- FEI Number
- 3012102437
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3200 Lakeville Hwy, Suite 120
- City
- Petaluma
- State
- CA
- ZIP
- 94954
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK210635
Owner / Operator
- Firm Name
- Synergy Health AST, LLC
- Operator Number
- 10028672
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Separator, Automated, Blood Cell, Diagnostic | GKT | Class 2 | Hematology | No | 2024-10-30 |
Proprietary Names
Terumo2207 (PT) - Rika Plasma Bottle
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)