FDA Registration
Active
🇺🇸 United States
SPS-1 STATIC PRESERVATION SOLUTION, MODELS SPS 1-1L, SPS 1-2L
Reg #: 3011292417
·
FEI: 3011292417
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Biovire, Inc.
- Registration Number
- 3011292417
- FEI Number
- 3011292417
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12501 E. Grand River
- City
- Brighton
- State
- MI
- ZIP
- 48116
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091656
Owner / Operator
- Firm Name
- Biovire, Inc.
- Operator Number
- 10059698
- Address
- 12501 E. Grand River
- City
- Brighton
- State
- MI
- Postal Code
- 48116
- Country
- US
- Correspondent
- Kimball Hall
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Perfusion, Kidney, Disposable | KDL | Class 2 | Gastroenterology, Urology | No | 2019-12-23 |
Proprietary Names
SPS-1 STATIC PRESERVATION SOLUTION, MODELS SPS 1-1L, SPS 1-2L
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)