FDA Registration
Active
🇺🇸 United States
UltraMIST System
Reg #: 1062240
·
FEI: 3006261799
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SANUWAVE, INC.
- Registration Number
- 1062240
- FEI Number
- 3006261799
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11495 Valley View Road
- City
- Eden Prairie
- State
- MN
- ZIP
- 55344
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140782
Owner / Operator
- Firm Name
- SANUWAVE, INC.
- Operator Number
- 9083571
- Address
- 11495 Valley View Road
- City
- Eden Prairie
- State
- MN
- Postal Code
- 55344
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wound Cleaner, Ultrasound | NRB | Class 2 | General, Plastic Surgery | No | 2020-09-02 |
Proprietary Names
UltraMIST System
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device