CloudTMS Edge

GUDID 04650075337783

The CloudTMS Edge 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.

NEUROSOFT, OOO

Magnetic neural stimulation system
Primary Device ID04650075337783
NIH Device Record Keya5c2af9e-3d43-4b19-820a-67d09aae76f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCloudTMS Edge
Version Model NumberMain unit
Company DUNS643212926
Company NameNEUROSOFT, OOO
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone617 8403263
EmailJjabre@teleemg.com
Phone617 8403263
EmailJjabre@teleemg.com
Phone617 8403263
EmailJjabre@teleemg.com
Phone617 8403263
EmailJjabre@teleemg.com
Phone617 8403263
EmailJjabre@teleemg.com
Phone617 8403263
EmailJjabre@teleemg.com
Phone617 8403263
EmailJjabre@teleemg.com
Phone617 8403263
EmailJjabre@teleemg.com
Phone617 8403263
EmailJjabre@teleemg.com
Phone617 8403263
EmailJjabre@teleemg.com
Phone617 8403263
EmailJjabre@teleemg.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104650075337783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBPTranscranial Magnetic Stimulator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-02
Device Publish Date2026-01-23

On-Brand Devices [CloudTMS Edge]

04650075337783The CloudTMS Edge system is indicated for the treatment of Major Depressive Disorder in adult pa
04650075333273No description

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