Evoqua Water Technologies LLC

FDA Device Registration & Listing · Minneapolis, MN, US · Registration 3019131

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3019131
FEI Number
3006475063
Entity Name
Evoqua Water Technologies LLC
City/State/Country
Minneapolis, MN, US
Establishment Address
14550 28TH AVENUE NORTH, Minneapolis, MN 55447, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Evoqua Water Technologies, LLC (Owner Number: 10057016)
Owner / Operator Contact Address
558 Clark Road, Tewksbury, MA 01876, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200670
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FIN Tank, Holding, Dialysis Gastroenterology, Urology Class 2 876.5820 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
LIF Dialyzer Reprocessing System Gastroenterology, Urology Class 2 876.5820 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2022-03-12
LIF Dialyzer Reprocessing System Gastroenterology, Urology Class 2 876.5820 2022-11-02
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
NII Disinfectant, Dialysate Delivery System Gastroenterology, Urology Class 2 876.5860 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
FIN Tank, Holding, Dialysis Gastroenterology, Urology Class 2 876.5820 2022-03-12
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-03-12

Official Correspondent

Robert Dudek

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Evoqua Water Technologies, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3017974963 Evoqua Water Technologies - Milpitas Milpitas, CA, US
3004057358 Evoqua Water Technologies LLC Indianapolis, IN, US
3013507157 Evoqua Water Technologies - Jacksonville Jacksonville, FL, US
3006029151 Evoqua Water Technologies - South Windsor South Windsor, CT, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K110578 Mar Cor Purification, Inc. MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM 2011-05-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-05 Ameriwater Inc 2
AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.

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3005021818 MEDICAL SOLUTIONS INTERNATIONAL, INC. Shawnee Mission, KS, US
1530185 AMERIWATER LLC. DAYTON, OH, US
3010867648 NELSON ENVIRONMENTAL TECHNOLOGIES, INC. Arlington, TX, US
2135346 CULLIGAN SOFT WATER SERVICE CO. Minnetonka, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019131. Last updated year: 2026. Please use registration number 3019131 when referencing this establishment in official correspondence.
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