Consulting Wallah › Device Explorer › Other devices › Reverse-osmosis water purification system
Device Explorer · FDA GUDID · GMDN 14437

Reverse-osmosis water purification system

An assembly of devices designed to remove unwanted contaminants (bacteria, viruses, chemicals, dissolved substances) from water using osmotic pressure applied to one side of a selective membrane. The system removes ions, large molecules (e.g. proteins, glucose

US‑registered devices396in commercial distribution
Companies9labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Mar Cor Purification, Inc.15038%
Vivonic Gmbh6115%
Biolab Equipment Ltd5313%
B.Braun Avitum Ag4110%
Better Water, Llc3810%
Ameriwater, Llc318%
Speciality Water Technology144%
Isopure, Corp.62%

Top labelers

CompanyDevicesShare
Mar Cor Purification, Inc.15038%
Vivonic Gmbh6115%
Biolab Equipment Ltd5313%
B.Braun Avitum Ag4110%
Better Water, Llc3810%
Ameriwater, Llc318%
Speciality Water Technology144%
Isopure, Corp.62%
Evoqua Water Technologies Corp.21%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AquaB LITEAquaDETECTORVisual LED IndicatorAquaAAquaBplusAquaCAquaBplus & AquaBplus B2 & AquaBplus HFAquaBplus & AquaBplus HFAquaBplus & AquaBplus B2Aquaboss®AQUAbase®MD490 Reverse Osmosis SystemMD480 Reverse Osmosis SystemMD470 Reverse Osmosis SystemMD460 Reverse Osmosis SystemMD440 Reverse Osmosis System

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 Purification357
FIPSUBSYSTEM, WATER PURIFICATION38
FIPSubsystem, water purification3

GMDN & GCC registration

  • GMDN code 14437 · non‑implantable
  • Single‑use 0% · 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

Weight (Pound) · 225Height (Inch) · 225Depth (Inch) · 225Width (Inch) · 225

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

How many reverse-osmosis water purification system products are registered in the US?

396 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Reverse-osmosis water purification system", from 9 companies. The largest labeler is Mar Cor Purification, Inc. with 38% of records.

Which FDA product codes apply?

FIP (Subsystem, Water Purification), FIP (SUBSYSTEM, WATER PURIFICATION), FIP (Subsystem, water purification)

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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