FDA Registration
Active
🇺🇸 United States
WAVES
Reg #: 2123774
·
FEI: 2123774
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WATERS MEDICAL SYSTEMS, LLC
- Registration Number
- 2123774
- FEI Number
- 2123774
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2900 37th St NW, Building 003
- City
- ROCHESTER
- State
- MN
- ZIP
- 55901
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111521
Owner / Operator
- Firm Name
- Waters Medical Systems LLC
- Operator Number
- 10024390
- Address
- 2900 37th St NW, Building 003
- City
- Rochester
- State
- MN
- Postal Code
- 55901
- Country
- US
- Correspondent
- Ashley Banks
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Perfusion, Kidney | KDN | Class 2 | Gastroenterology, Urology | No | 2012-12-12 |
Proprietary Names
WAVES
Establishment Types
Manufacture Medical Device