Consulting Wallah › Device Explorer › Other devices › Thermoplastic-moulding water bath
Device Explorer · FDA GUDID · GMDN 17526

Thermoplastic-moulding water bath

A mains electricity (AC-powered) water bath specifically designed for the warming/heating of mouldable plastic materials (thermoplastics) used to create body positioning and body fixation devices, splints, and orthotic devices. It will typically consist of a l

US‑registered devices72in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription8%Rx‑only share
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Share of device records

Whitehall Manufacturing Co6692%
Medtec, Inc.46%
Inion Oy23%

Top labelers

CompanyDevicesShare
Whitehall Manufacturing Co6692%
Medtec, Inc.46%
Inion Oy23%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Inion® Universal instrumentsWaterbathGas StrutBath LinerWhitehall ThermalatorsThermasplint

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

FDA product codes

CodeNameDevices
IRQUnit, Heating, Powered66
IRQUNIT, HEATING, POWERED4
IYEAccelerator, linear, medical3
KPYShield, protective, personnel2

GMDN & GCC registration

  • GMDN code 17526 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 8% · OTC 53%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 2Width (Centimeter) · 2Length (Inch) · 1

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

How many thermoplastic-moulding water bath products are registered in the US?

72 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Thermoplastic-moulding water bath", from 3 companies. The largest labeler is Whitehall Manufacturing Co with 92% of records.

Which FDA product codes apply?

IRQ (Unit, Heating, Powered), IRQ (UNIT, HEATING, POWERED), IYE (Accelerator, linear, medical), KPY (Shield, protective, personnel)

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.

How do I get quotes?

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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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