Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005544459

FEI Number

3008241044

Entity Name

STEELCO S.P.A.

City/State/Country

Riese Pio X Treviso, IT

Establishment Address

Via Balegante, 27, Riese Pio X Treviso 31039, IT

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

STEELCO S.P.A. (Owner Number: 10026042)

Owner / Operator Contact Address

Via Balegante, 27, Via del Lavoro, 6, Riese Pio X, IT-TV 31039, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213545

PMA Number

N/A

All Registered Proprietary Names

Steelco DS 600 G2 DS 750 DS 610 DS 1000 LC 70 DS 650 PWD 8534 DS 600 DS 800 DS 900 PWD 6122 PWD 8532 DS 610 G2 DS 50 LC 80 PWD 6121 US 300 TW 3000 DS 500 PWD 8531 US 1000 US 80 US 200 US 900 US 100 ED 100 ED 150 AD 400 ID 300 ED 250 ED 200 VS 262839 VS 262869 VS 262851

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEC	Disinfector, Medical Devices	General Hospital	Class 2	880.6992	2008-06-03
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2020-09-08
JRJ	Unit, Drying	Clinical Chemistry	Class 1	862.2050	2017-02-08
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2023-10-18

Official Correspondent

No official correspondent registered.

US Agent Details

Steven Sutton Business: SteelcoBelimed Inc. Email: steven.sutton@belimed.com Phone: (843) 6074608

Related Public Records

Same Entity

STEELCO S.P.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2026	Getinge Disinfection Ab Ljungadalsgatan	2	Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Z-0018-2014	Getinge Disinfection Ljungadalsgatan	2	Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005544459. Last updated year: 2026. Please use registration number 3005544459 when referencing this establishment in official correspondence.