← Back to catalogue

Neurosoft

FDA UDI

Class II (US FDA UDI)

by Neurosoft, Ooo

Identity

Trade Name
Neurosoft FDA UDI
Generic Name
Magnetic neural stimulation system FDA UDI
Device Name
The Neurosoft TMS system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode. FDA UDI
Model / Reference
TMS FDA UDI
Description
The Neurosoft TMS system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode. FDA UDI

Identifiers

Primary DI / UDI-DI
04650075330197 FDA UDI
510(k) Number
K160309 FDA UDI
FDA Product Code
OBP FDA UDI
GMDN Term
Magnetic neural stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5805 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Magnetic neural stimulation system

Neurosoft by Neurosoft, Ooo — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Magnetic neural stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Neurosoft, Ooo

Sources (1)

  • FDA UDI d599e220-8dbf-4a9d-ad10-85624d0a03fe 35 fields · synced May 30, 2026