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CloudTMS Edge for OCD

FDA UDI

Class II (US FDA UDI)

by Neurosoft, Ooo

Identity

Trade Name
CloudTMS Edge for OCD FDA UDI
Generic Name
Magnetic neural stimulation system FDA UDI
Device Name
The CloudTMS Edge 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
Main unit FDA UDI
Description
The CloudTMS Edge 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
04650075335895 FDA UDI
510(k) Number
K233742 FDA UDI
FDA Product Code
QCI FDA UDI
GMDN Term
Magnetic neural stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5802 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

Yes

FDA UDI

Category: Magnetic neural stimulation system

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

Similar devices

Also classified as Magnetic neural stimulation system.

Cleared under the same submission

K233742 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurosoft, Ooo

Sources (1)

  • FDA UDI 7b9d1265-c341-48c6-a785-fbd6a0e77a85 35 fields · synced Jun 8, 2026