Data / Medical devices / Italy / M&T SRL

M&T SRL: FDA-registered device maker in rimini, Italy, 3 510(k) clearances

Name: M&T SRL FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

M&T SRL is registered with the FDA (registration 3008442971) in rimini, Italy. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 20, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008442971
Address: via pietrarubbia 32F, rimini, Italy, 47922
Owner or operator: M&T srl (10052371)
Roles: Manufacturer
First device listed: November 13, 2019
Registered through: 2026
Brand names listed: MTONE DIAMOND, MTONE EVO, MTONE/Dus

Devices it lists

Device	Product code	Class	Role	Source
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	2	Manufacturer	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument	ONE	2	Manufacturer	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	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
September 20, 2024	K240604	MTONE EVO (MTONE EVO)	GEX	Substantially Equivalent	M&T S.R.L.	accessdata.fda.gov
April 24, 2020	K192856	MT One	GEX	Substantially Equivalent	M&T S.R.L.	accessdata.fda.gov
October 17, 2019	K191942	MT One Diamond	GEX	Substantially Equivalent	M&T S.R.L.	accessdata.fda.gov

Compare with other makers

Updated September 20, 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.