AQUAMEDIX

FDA Device Registration & Listing · Eden Prairie, MN, US · Registration 3009893608

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
3009893608
FEI Number
3009893608
Entity Name
AQUAMEDIX
City/State/Country
Eden Prairie, MN, US
Establishment Address
7169 Shady Oak Road, Eden Prairie, MN 55344, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
AquaMedix (Owner Number: 10057164)
Owner / Operator Contact Address
7169 Shady Oak Road, Eden Prairie, MN 55344, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

AquaMedix Hollow Fiber Membrane Filter Micro 10" AquaMedix Hollow Fiber Membrane Filter Micro 20" AquaMedix Hollow Fiber Membrane Filter Dual Stage-CL 10"

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JRL Unit, Filter, Membrane Clinical Chemistry Class 1 862.2050 2018-03-01
JRS Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) Clinical Chemistry Class 1 862.2050 2018-03-01

Official Correspondent

Jack Benson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AquaMedix
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K812750 Instrumentation Laboratory CO IL 703, STAT SEPARATOR 1982-01-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009893608. Last updated year: 2026. Please use registration number 3009893608 when referencing this establishment in official correspondence.
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