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Device Explorer · FDA GUDID · GMDN 44344

Combination water purification system

An assembly of electrically-powered devices, or stand-alone device, designed to remove unwanted chemical, particulate, and/or biological contaminants from water. This system purifies water using a combination of methods including particulate filtration, chemic

US‑registered devices143in commercial distribution
Companies8labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Speciality Water Technology10775%
Better Water, Llc2719%
Histosonics, Inc.32%
Outset Medical, Inc.21%
Nelson Environmental Technologies Inc11%
Isopure, Corp.11%
Nxstage Medical, Inc.11%
A-Dec, Inc.11%

Top labelers

CompanyDevicesShare
Speciality Water Technology10775%
Better Water, Llc2719%
Histosonics, Inc.32%
Outset Medical, Inc.21%
Nelson Environmental Technologies Inc11%
Isopure, Corp.11%
Nxstage Medical, Inc.11%
A-Dec, Inc.11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DI DIVERT, WALL-MNT, W/RESIS MONWater Purification System for HemodialysisComplete Water Treatment SystemHistoSonicsTabloCart™ with Prefiltration Drawer"POST-TREAT, .03 30"", 208V""POSTTREAT, .03 30"", 208V, DTD""POSTTREAT, .03 30"", 230V, DTD"POSTTREAT, 4UF, 230V, DTDPOSTTREAT, 4UF, 208V, DTDPOSTTREAT, 3UF, 208V, DTDPOSTTREAT, 2UF, 208V, DTDPOSTTREAT RACK, 4UF, 208V, 2 PUMPSPOSTTREAT RACK, 4UF, 208V, 1 PUMP"POSTTREAT RACK, .03 30"", 208V, 2 PUMPS""PRETREAT, 1"", 208V, CPVC, SHORT, AC"

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
FIPSubsystem, Water Purification154
FKRSubsystem, Proportioning4
JRSPurifier, Water (Absorption, Deionization, Membrane Filter, 2
KDIDialyzer, High Permeability With Or Without Sealed Dialysate2
QYJDental Waterline Treatment Cartridge1

GMDN & GCC registration

  • GMDN code 44344 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 98% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many combination water purification system products are registered in the US?

143 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Combination water purification system", from 8 companies. The largest labeler is Speciality Water Technology with 75% of records.

Which FDA product codes apply?

FIP (Subsystem, Water Purification), FKR (Subsystem, Proportioning), JRS (Purifier, Water (Absorption, Deionization, Membrane Filter, ), KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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