CloudTMS

FDA UDI

Class II (US FDA UDI)

by Neurosoft, Ooo

Identity

Trade Name: CloudTMS FDA UDI
Generic Name: Magnetic neural stimulation system FDA UDI
Device Name: The CloudTMS 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. The Cloud TMS stimulator is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). FDA UDI
Model / Reference: CloudTMS FDA UDI
Description: The CloudTMS 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. The Cloud TMS stimulator is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). FDA UDI

Identifiers

Primary DI / UDI-DI: 04650075330296 FDA UDI
FDA Product Code: OBP FDA UDI
QCI FDA UDI
GMDN Term: Magnetic neural stimulation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5805 FDA UDI
882.5802 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Magnetic neural stimulation system

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Neurosoft, Ooo

Sources (1)

FDA UDI d20a839b-9009-45a0-86ec-e406bb48d54e 34 fields · synced May 30, 2026