Data / Medical devices / Italy / Eb Neuro, S.P.A.

Eb Neuro, S.P.A.: FDA-registered device maker in FLORENCE Tuscany, Italy, 1 510(k) clearance

Name: Eb Neuro, S.P.A. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Eb Neuro, S.P.A. is registered with the FDA (registration 9617286) in FLORENCE Tuscany, Italy. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 4, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9617286
FEI number: 3003208775
Address: Via Pietro Fanfani 97/A, FLORENCE Tuscany, Italy, 50127
Owner or operator: EB NEURO, S.P.A. (9043444)
Roles: Contract manufacturer, Manufacturer
First device listed: July 12, 2010
Registered through: 2026
Brand names listed: BE MICRO, BE Plus PRO, Neurotravel LIGHT, Trea

Devices it lists

Device	Product code	Class	Role	Source
Amplifier, Physiological Signal	GWL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Contract manufacturer	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	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
September 4, 2024	K242305	BE Plus PRO, Neurotravel LIGHT	GWL	Substantially Equivalent	Eb Neuro S.P.A.	accessdata.fda.gov

Compare with other makers

Updated September 4, 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.