Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043725

FEI Number

3009631751

Entity Name

GILARDONI S.P.A.

City/State/Country

MANDELLO DEL LARIO Lecco, IT

Establishment Address

VIA ARTURO GILARDONI, 1, MANDELLO DEL LARIO Lecco 23826, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GILARDONI S.p.A. (Owner Number: 9003480)

Owner / Operator Contact Address

via A. Gilardoni 1, Mandello del Lario, IT-LC 23826, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201177

PMA Number

N/A

All Registered Proprietary Names

IXION III HF GENERATOR RADGIL2 US

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	1997-11-20
MOT	Irradiator, Blood To Prevent Graft Versus Host Disease	Unknown	Class U	N/A	2020-08-19

Official Correspondent

Daniele Maggioni

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

GILARDONI 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
K950291	Fischer Imaging Corp.	DIGITAL 625HF	1995-03-23

Similar Registrations

Registration Number	Establishment Name	Location
1483291	Varex Imaging Corporation	Franklin Park, IL, US
3007603422	Althea US, Inc.	Goodlettsville, TN, US
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
3003768251	Philips Medical Systems DMC GmbH	HAMBURG, DE
1450503	SUMMIT INDUSTRIES, LLC	Niles, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043725. Last updated year: 2026. Please use registration number 8043725 when referencing this establishment in official correspondence.