Consulting Wallah › Device Explorer › Other devices › Steam sterilizer
Device Explorer · FDA GUDID · GMDN 38671

Steam sterilizer

A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to

US‑registered devices1,012in commercial distribution
Companies28labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription1%Rx‑only share
ShareLinkedIn

Share of device records

Steris Mexico, S. De R.L. De C.V.47547%
Getinge Ic Production Poland Sp Z O O25325%
Tuttnauer Israel Ltd.737%
Midmark Corporation424%
Primus Sterilizer Company, Llc273%
Dent4You Ag232%
W & H Sterilization Srl212%
Skytron Llc111%

Top labelers

CompanyDevicesShare
Steris Mexico, S. De R.L. De C.V.47547%
Getinge Ic Production Poland Sp Z O O25325%
Tuttnauer Israel Ltd.737%
Midmark Corporation424%
Primus Sterilizer Company, Llc273%
Dent4You Ag232%
W & H Sterilization Srl212%
Skytron Llc111%
Henry Schein, Inc.101%
Changsha Yingtai Instrument Co., Ltd91%
Consolidated Machine Corporation91%
Enbio Group Ag81%

Company = labeler of record on GUDID. 28 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

STATIM 2000 G4 Cassette Autoclave3870HSG5596-1R-R-USA5596-1R-L-USAT-Edge 11Model 4472T-Edge 102540MKAModel 69180-2AModel 69180-1AModel 69120-2AModel 69120-1AModel 66120-2VModel 66120-1VModel 6990-2AModel 6990-1A

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

FDA product codes

CodeNameDevices
FLESterilizer, Steam653
FLESterilizer, steam531
LRJDisinfectant, Medical Devices15
OUGMedical device data system5
PDGElectrosurgical Vessel And/Or Tissue Sealer. With Built-In G1

GMDN & GCC registration

  • GMDN code 38671 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 1% · OTC 83%
  • 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 (Liter) · 8Length (Inch) · 6Width (Inch) · 6Height (Inch) · 6Weight (Pound) · 6

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

No closely related category with 50+ devices.

How many steam sterilizer products are registered in the US?

1,012 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Steam sterilizer", from 28 companies. The largest labeler is Steris Mexico, S. De R.L. De C.V. with 47% of records.

Which FDA product codes apply?

FLE (Sterilizer, Steam), FLE (Sterilizer, steam), LRJ (Disinfectant, Medical Devices), OUG (Medical device data system)

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?

Add steam sterilizer to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Steam sterilizer

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying steam sterilizer for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →