Flow Neuroscience AB

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3045752358	3045752358	Flow Neuroscience AB	1	N	2026-01-01	Sodra Tullgatan 3 Malmo Skane SE 211 40

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
351221	1125621878	P230024	Flow FL-100	JXK	2025-12-08

GUDID#

Flow Neuroscience - The FL-100 is intended for the treatment of moderate to severe major depressive disorder in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 and older who are not considered treatment refractory to medication. For prescription use only (Rx only). Kit comprising of: FL-100 (US version) UDI: 07314581000001 Two boxes each with 24 single-use, non-sterile electrode pads. UDI: 17314585010003 Kit for first prescription to a patient.
Flow Neuroscience AB
2026-07-24
Flow Neuroscience - Kit for US market comprises of: 2x 17314585010003 (two boxes of 24 PADS each)
Flow Neuroscience AB
2026-07-24
Flow Neuroscience - The FL-100 is intended for the treatment of moderate to severe major depressive disorder in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 and older who are not considered treatment refractory to medication. For prescription use only (Rx only).
Flow Neuroscience AB
2026-06-24
Flow Neuroscience - Electrode cellulose and saline pads (two per sachet), only for use with the FL-100 tDCs system. Rx Only.
Flow Neuroscience AB
2026-07-02