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Nexstim NBS System 5 - HSA Registration DE0508998

Access comprehensive regulatory information for Nexstim NBS System 5 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508998 and owned by Nexstim Plc.. The device was registered on February 28, 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
DE0508998
Nexstim NBS System 5
HSA Registration Number: DE0508998
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Product Description

The Nexstim Navigated Brain Stimulation System 5 (NBS System) is intended to be used for localization and assessment of the motor cortex and motor tract integrity for pre-procedural planning purposes. In addition, the NBS System provides the user with the capability to perform clinical research with rTMS. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0508998
Registration Date
February 28, 2024
Retention Due Date
February 27, 2026
Product Owner
Short Name
Nexstim Plc.
Address
Elimäenkatu 9 B, 00510, Helsinki, FINLAND
Registrant
Address
1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #07-21, SINGAPORE 159471
Model Information
Model Name(s)
NBS orange head tracker 20 pcs Nexstim computer set Cooling Unit EU Network firewall Compact coil tracker Nexstim TMS II Nexstim Focal Coil with tracker Operator Chair NexSpeech Analyzer Software for Planning Station Patient chair Tracking system Nexstim Cooled coil with coil tracker and adjustment ring RFID reader Isolation transformer NBS 5 Motor Mapping System NexSpeech System rTMS System Patient chair cushion set Patient chair footrest cushion Nexstim cart Nexstim EMG II NBS displays NBS System components NBS main software Nexstim NBT White head tracker 20 pcs Coil positioning holder Nexstim Planning Station SFTP Data Transfer Module Nexstim Report Maker
Model Identifier(s)
NX103376 NX113260 NX137082 NX141819 NX75105 NX76636 NX76809 NX76816 NX81149 NX89022 NX89447 NX89460 NX91019 NX92296 NX92523 NX92527 NX92528 NX92676 NX92677 NX92696 NX93115 NX93138 NX93165 NX93232 NX93874 NX94066 NX94067 NX94068 NX96316