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Device Explorer · FDA GUDID · GMDN 35424

Surgical utensil washer/disinfector

A mains electricity (AC-powered) unit designed to wash (remove dirt/stains), decontaminate (remove organic debris), and disinfect (destroy microorganisms) reusable surgical instruments, bowls, anaesthesia equipment components, and some surgical footwear. Most

US‑registered devices119in commercial distribution
Companies4labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Steelco Spa8672%
Getinge Disinfection Ab2824%
Miele & Cie. Kg43%
Scican Ltd11%

Top labelers

CompanyDevicesShare
Steelco Spa8672%
Getinge Disinfection Ab2824%
Miele & Cie. Kg43%
Scican Ltd11%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HYDRIM C61W G4 Instrument WasherGetinge 86-SeriesGETINGE 46-SERIESGETINGE CM320-SERIESGETINGE 91-SERIESGETINGE 86-SERIESGETINGE WD 15 CLAROGETINGE WD 14 TABLOGETINGE 90-SERIESGETINGE 88-SERIESMieleSteelco

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

FDA product codes

CodeNameDevices
MECDisinfector, Medical Devices117
MECDisinfector, medical devices3
LDSDevice, Pasteurization, Hot Water1
FLGCleaner, Ultrasonic, Medical Instrument1

GMDN & GCC registration

  • GMDN code 35424 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 0% · 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 surgical utensil washer/disinfector products are registered in the US?

119 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical utensil washer/disinfector", from 4 companies. The largest labeler is Steelco Spa with 72% of records.

Which FDA product codes apply?

MEC (Disinfector, Medical Devices), MEC (Disinfector, medical devices), LDS (Device, Pasteurization, Hot Water), FLG (Cleaner, Ultrasonic, Medical Instrument)

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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