Pure Global

Medtronic Nim-Eclipse NS System - HSA Registration DE0011381

Access comprehensive regulatory information for Medtronic Nim-Eclipse NS 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 DE0011381 and owned by Medtronic Xomed. The device was registered on October 19, 2012.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0011381
Medtronic Nim-Eclipse NS System
HSA Registration Number: DE0011381
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

intended for use to monitor sensory and motor pathways and to provide information to determine the state of blood flow in the intracranial and extracranial vascular arteries in adults. The instrument uses electroencephalography (EEG), electromyography (EMG), motor and sensory evoked potentials and nerve potentials and Doppler analysis. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The system is used in the operating room and critical care areas to provide health care professionals with information to guide surgery and to assess a patient's neurological and vascular status. Doppler analysis is not to be used for Obstetrics.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Neurology
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0011381
Registration Date
October 19, 2012
Change Notification Approval Date
December 13, 2023
Retention Due Date
October 18, 2025
Product Owner
Short Name
Medtronic Xomed
Address
6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
Power Cord, UK, 6 Meter Power Cord, European, 6 Meter Nim Pedicle Probe-Thoracic Nim Pedicle Access needle Nim Pedicle Probe- Lumbar Nim Pedicle Probe- Straight Nim XPAK Probe Earphones, Insert Headband, TCD Bilateral Bipolar Probe, 100mm Bipolar Probe, 100mm Preamplifier Cable Stimulator Cable, 20 Ft (6m) Cable, 8 Ft (2.4m) Cable, Adapter Computer AC Jumper Cable Concentric Probe, 100mm Cord, Hospital Grade Line Power Cord CPCA16 AUS/NZ 3 METER Power Cord CPCINDIA 16 2.5 METER Cable, Power Controller Jumper, 3ft (1m) Cable, Power Controller Jumper, 6Ft (1.8m) Power Cord CPP500AUS Printer AUS/NZ Power Cord CPP500EUR Printer Europe Power Cord CPP500IND Printer India Power Cord CPP500UK Printer UK Controller USB Jumper Cable Adapter, Video Capture Digital Preamplifier Corkscrew Electrode, 1.2m Single Ground Electrode, 2.0m Corkscrew Electrode, 1.2m Extension Lead Wire, White Extension Lead Wire, Black Extension Lead Wire, Red Extenstion Lead Wire, Green Lead Wire, Assorted Single Electrode, 1.5m Single Electrode, 2.5m Single Electrode, 1.5m Single Electrode, 2.5m Dual Electrode, 1.5m Dual Electrode, 2.5m Dual Electrode, 1.5m Dual Electrode, 2.5m Single Electrode, 1.5m Single Electrode, 2.5m Dual Electrode, 1.5m Dual Electrode, 2.0m Dual Electrode, 2.5m Nim-Eclipse Controller Stimulator Extender Vital Sign Flush Tip Probe, 100 mm Flush Tip Probe, 100 mm Impedance Test Connector Cable Cart Cart Mute Detector Probe ESU Mute Probe Splitter Direct Nerve Probe, 100mm Direct Nerve Probe, 100mm Monitor, Desktop Mouse,Computer Nim-Eclipse Computer Notebook Nim-Eclipse Computer Notebook, German Nim-Eclipse Computer Notebook, Spanish Nim-Eclipse Computer, Notebook, Frnch Nim-Eclipse Computer, Notebook, Italian NIM-ECLIPSE Computer, Notebook, E4 Stimulated Dilator Nim- Eclipse Computer, Desktop NIM-ECLIPSE Computer, Desktop, E4 Power Controller Power Controller, 240V Pulse Oximeter Clip Eclipse Pulse Oximeter Module Printer with Bluetooth Port Pedicle Screw Probe, 100 mm Pedicle Screw Probe, 175 mm Ball Tip Probe, 230 mm Ball Tip Probe, 100mm Ball Tip Probe, 175mm Bent ball tip Probe, 230mm Pulse Oximeter Finger, Toe Lead Clip Replacement Air Tube, with Cable Replacement Air Tube Surface Preamplifier Module Transporter Case TCD Package Stand Alone TCD Module Probe Camera LED Goggles
Model Identifier(s)
1895824 1895825 8225719 8225720 8225747 8225759 8225769 AE102 BHB500 BNP2001 BNP2002 CDAQ916 CEEX20 CEEX98 CMDA732 CNCPS101 CNP2001 CPC16 CPCA16 CPCINDIA16 CPJ203 CPJ206 CPP500AUS CPP500EUR CPP500IND CPP500UK CUSB100 CVC100 DAQ916 DME1001 DME1004 DME2002 DSE0001 DSE0002 DSE0003 DSE0004 DSE0005 DSE1115 DSE1125 DSE2115 DSE2125 DSE3115 DSE3125 DSE4115 DSE4125 DSN1260 DSN1299 DSN2260 DSN2280 DSN2299 ECLC EEX901 EPM3200 FTP1001 FTP2001 ITP916 LEA300 MCLT16 MCNW16 MDP201 MDPA201 MNP1001 MNP2001 MON19 MSM100 NCCPU NCCPU-DE NCCPU-ES NCCPU-FR NCCPU-IT NCCPUE4 NSD2750 NWCPU NWCPUE4 P216 P226 POC1002 POC180 PP500 PSP1000 PSP1001 PSP1002 PSP2000 PSP2001 PSP2002 PXC2002 RMA1015 RMA1016 SPM608 TC32 TCD16 TCD500 TCD500P VC330 VG202