FDA Registration
Active
🇳🇱 Netherlands
FLW-0010 Lasso Tubing
Reg #: 3006986257
·
FEI: 3006986257
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ThermaSolutions Europe B.V.
- Registration Number
- 3006986257
- FEI Number
- 3006986257
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Takkebijsters 41
- City
- Breda Noord-Brabant
- Country
- NL
Owner / Operator
- Firm Name
- THERMASOLUTIONS LLC.
- Operator Number
- 9082263
- Address
- 1889 Buerkle Road
- City
- White Bear Lake
- State
- MN
- Postal Code
- 55110
- Country
- US
- Correspondent
- Rhea Johny
US Agent
- Business Name
- THERMASOLUTIONS, LLC
- Contact Name
- Gregg Giza
- Address
- 1889 Buerkle Road, --
- City
- White Bear Lake
- State
- MN
- ZIP
- 55110
- Country
- US
- [email protected]
- Phone
- 651 2093900
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2022-12-27 |
Proprietary Names
FLW-0010 Lasso Tubing
FLW-0111 Long Lasso Tubing
FLW-0120 Inflow Tubing
PAK-0112 Inflow and Outflow Tubing Pack
Establishment Types
Export Device to the United States But Perform No Other Operation on Device