FDA Registration
Active
🇺🇸 United States
Evoqua Water Technologies LLC
Reg #: 3019131
·
FEI: 3006475063
·
Expires 2026
Products
6
Proprietary Names
27
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- Evoqua Water Technologies LLC
- Registration Number
- 3019131
- FEI Number
- 3006475063
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14550 28TH AVENUE NORTH
- City
- Minneapolis
- State
- MN
- ZIP
- 55447
- Country
- US
Regulatory Submissions
- 510(k) Number
- K003560
Owner / Operator
- Firm Name
- Evoqua Water Technologies, LLC
- Operator Number
- 10057016
- Address
- 558 Clark Road
- City
- Tewksbury
- State
- MA
- Postal Code
- 01876
- Country
- US
- Correspondent
- Robert J Dudek
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tank, Holding, Dialysis | FIN | Class 2 | Gastroenterology, Urology | No | 2022-03-12 |
| Subsystem, Water Purification | FIP | Class 2 | Gastroenterology, Urology | No | 2022-03-12 |
| Dialyzer Reprocessing System | LIF | Class 2 | Gastroenterology, Urology | No | 2022-03-12 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2022-03-12 |
| Disinfectant, Dialysate Delivery System | NII | Class 2 | Gastroenterology, Urology | No | 2022-03-12 |
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | Class 2 | Gastroenterology, Urology | No | 2022-03-12 |
Proprietary Names
Bicarbonate Mixing Systems
HX2 Reverse osmosis Water Purification System
RENATRON
WRO 300 & 300H Reverse Osmosis Units
Renalin Sterilant
Renalin Indicator Test Strips
Millennium HX Portable RO System
SDI & Carbon Tanks for Hemodialysis
Complete Water Treatment System for Hemodialysis
Ozone Generator
4400 & 8400 Portable RO systems
POSICLEAR FILTER
Millennium HX RO System
Dialysis Water Treatment & Distribution System
Water Treatment System for Hemodialysis
EON Portable RO Water Purification System
Hemodialysis Water Purification System
Hemodialysis Total Water Treatment System
Dialysis Holding Tank
CWP100 & WRO H Central Water Treatment System
WRO 300 Water Purification System
GEM Reverse Osmosis Unit
S700 & 800 Series Reverse Osmosis System
EON Portable Reverse Osmosis System
Solution Delivery System
RenaPure
23G Reverse Osmosis Equipment
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198