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Device Explorer · FDA GUDID · GMDN 36749

Ultrasonic-cleaning water bath

An electrically-powered device intended to be used to clean instruments/utensils with ultrasonic waves transmitted from its integral transducers through water contained in a bath. A dedicated cleaning agent may be added to the water to enhance the cleaning eff

US‑registered devices200in commercial distribution
Companies18labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription7%Rx‑only share
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Share of device records

Coltene/Whaledent Inc4924%
Getinge Disinfection Ab3316%
Ultra Clean Systems, Inc.2714%
Henry Schein, Inc.2512%
Steelco Spa158%
Brandmax Inc.136%
Sonic Systems, Inc.116%
Medisafe Uk Limited84%

Top labelers

CompanyDevicesShare
Coltene/Whaledent Inc4924%
Getinge Disinfection Ab3316%
Ultra Clean Systems, Inc.2714%
Henry Schein, Inc.2512%
Steelco Spa158%
Brandmax Inc.136%
Sonic Systems, Inc.116%
Medisafe Uk Limited84%
Midmark Corporation52%
Jmu Dental, Inc42%
Prisman Inc.21%
Darby Dental Supply, Llc21%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

StatClean Ultrasonic CleanerUltra Clean SystemsNiagaraMonolith Ultrasonic Cleaner Powder conc.Monolith Ultrasonic Cleaner conc.Darby Dental Supply, LLCBrandMax Sonic ShineBrandMax Tri-CleanJMUMidmarkBelimedGetingeSonic SystemsSonic Systems, IncSP AdapterD5 Adapter

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

FDA product codes

CodeNameDevices
FLGCleaner, Ultrasonic, Medical Instrument146
FLGCleaner, ultrasonic, medical instrument53
MECDisinfector, Medical Devices1
MDZCleaners, Medical Devices1

GMDN & GCC registration

  • GMDN code 36749 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 7% · OTC 17%
  • 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 ultrasonic-cleaning water bath products are registered in the US?

200 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ultrasonic-cleaning water bath", from 18 companies. The largest labeler is Coltene/Whaledent Inc with 24% of records.

Which FDA product codes apply?

FLG (Cleaner, Ultrasonic, Medical Instrument), FLG (Cleaner, ultrasonic, medical instrument), MEC (Disinfector, Medical Devices), MDZ (Cleaners, Medical Devices)

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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