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Magstim Horizon 3.0 TMS Therapy System - HSA Registration DE0509785

Access comprehensive regulatory information for Magstim Horizon 3.0 TMS Therapy System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509785 and owned by The MAGSTIM Company Limited. The device was registered on September 16, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0509785
Magstim Horizon 3.0 TMS Therapy System
HSA Registration Number: DE0509785
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Product Description

The Horizonยฎ 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from antidepressant medication in the current episode. The Horizonยฎ 3.0 TMS Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings, including physiciansโ€™ offices, clinics, and hospitals.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509785
Registration Date
September 16, 2024
Retention Due Date
September 15, 2025
Product Owner
Short Name
Magstim
Address
Spring Gardens, Whitland, Carmarthenshire, Wales, SA34 OHR, UNITED KINGDOM
Registrant
Address
8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Importer
Address
8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Model Information
Model Name(s)
MT Remote Coil HORIZON Interface Unit 3.0 Horizon 3.0 EZ Camera Stand Horizon 3.0 Break Control Foot Switch HORIZON 3.0 E-z Cool Coil Ez Cart 3.0 Horizon 3.0 Coil Holder Horizon 3.0 Holding Arm Horizon 3.0 Holding Arm Break TMS Patient Cap, Size Small (S) TMS Patient Cap, Size Medium (M) TMS Patient Cap, Size Large (L) TMS Patient Cap, Size Extra Large (XL) HORIZON Mainframe 3.0 HORIZON PSU 3.0 Ez Cart Mast Extension 3.0 StimGuide Pro E-z Coil Tracker Toolย  StimGuide Pro MT Coil Tracker Toolย  StimGuide Pro Head Referenceย  StimGuide Pro Pointer Tool
Model Identifier(s)
4990-00 5445-00-50 5471-00-50 5473-00 5620-00-50 5625-00 5630-00 5635-00 5763-01 5770-00 5771-00 5772-00 5773-00 5800-00 5801-00 5835-00-50 5966-10 5967-01ย  5968-00ย  6438-00