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Device Explorer · FDA GUDID · GMDN 63385

Medical device cleaning agent

A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disi

US‑registered devices1,078in commercial distribution
Companies51labelers on GUDID
Single‑use71%of device records
Sterile0%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Ruhof Corporation60556%
Alconox Inc838%
Skytron Llc787%
Steris Corporation646%
Microcare, Llc283%
Quadralene Limited252%
Southmedic Incorporated212%
Germiphene Corporation182%

Top labelers

CompanyDevicesShare
Ruhof Corporation60556%
Alconox Inc838%
Skytron Llc787%
Steris Corporation646%
Microcare, Llc283%
Quadralene Limited252%
Southmedic Incorporated212%
Germiphene Corporation182%
Keystone Industries111%
Palmero Healthcare Llc91%
Batrik Medical Manufacturing Inc81%
Chemische Fabrik Dr. Weigert Gmbh & Co. Kg71%

Company = labeler of record on GUDID. 51 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HIPHIP UltraXen QuadX 2x5LXen Neutral 15GXen Neutral 5GXen Sanizyme+ 15GXen Xcelerate+ LumenXen Neutral+ 15GXen Neutral+ 5GXen Neutral+ 5LXen Neutral 5LXen Sanizyme+ 5GXen Sanizyme+ 5LXen Xcelerate+Xen Universal+ 15GXen Universal+ 5G

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 Instrument790
FLGCleaner, ultrasonic, medical instrument136
MECDisinfector, medical devices69
MNLAccessories, Cleaning Brushes, For Endoscope20
NRDUnit, operative dental, accessories12
JCBDetergent11

GMDN & GCC registration

  • GMDN code 63385 · non‑implantable
  • Single‑use 71% · sterile 0% · Rx‑only 3% · OTC 65%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Gallon) · 32Total Volume (Fluid Ounce) · 10Total Volume (Liter) · 7Weight (Gram) · 4Total Volume (Milliliter) · 2Weight (Pound) · 2

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

How many medical device cleaning agent products are registered in the US?

1,078 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Medical device cleaning agent", from 51 companies. The largest labeler is Ruhof Corporation with 56% of records.

Which FDA product codes apply?

FLG (Cleaner, Ultrasonic, Medical Instrument), FLG (Cleaner, ultrasonic, medical instrument), MEC (Disinfector, medical devices), MNL (Accessories, Cleaning Brushes, For Endoscope)

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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