Data / Medical devices / Italy / Technix SPA

Technix SPA: FDA-registered device maker in Grassobbio Bergamo, Italy, 2 510(k) clearances

Name: Technix SPA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Technix SPA is registered with the FDA (registration 3008044777) in Grassobbio Bergamo, Italy. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 26, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3008044777
Address: Via E. Fermi, 45, Grassobbio Bergamo, Italy, 24050
Owner or operator: TECHNIX S.P.A. (10048870)
Roles: Contract manufacturer, Manufacturer
First device listed: March 13, 2015
Registered through: 2027
Brand names listed: DR 100s, Nautilus

Devices it lists

Device	Product code	Class	Role	Source
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Manufacturer	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 26, 2024	K233380	TRIDENT Mobile Fluoroscopy System	JAA	Substantially Equivalent	Dornier Medtech America	accessdata.fda.gov
April 18, 2022	K220871	Nautilus	JAA	Substantially Equivalent	Dornier Medtech America, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.