Singapore HSA registration DE0013376
Medtronic NIM-Eclipse SD System
Singapore·CLASS B·Medtronic Xomed·Registered July 15, 2013Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Neurology
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90189030
Registration information
- Registration Number
- DE0013376
- Registration Date
- July 15, 2013
- Change Notification Approval Date
- December 13, 2023
- Retention Due Date
- July 14, 2025
Product description
Nim Eclipse- Surgeon Directed System is intended for use to record, monitor, and stimulate/ record biopotential signals including electromyograph (EMG), evoked response and nerve/ muscle potentials and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction. They system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots.
Product Owner
- Name
- Medtronic Xomed
- 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 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 Nim-Eclipse Controller Vital Sign Impedance Test Connector Cable Mute Detector Probe ESU Mute Probe Splitter Keyed Corkscrew Electronic Medtronic Monitor, Desktop 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 Needle Electrode Kit Needle Electrode Stimulated Dilator Nim- Eclipse Computer, Desktop NIM-ECLIPSE Computer, Desktop, E4 Patient Interface Module Power Controller Power Controller, 240V Eclipse Pulse Oximeter Module Electrode Adaptor Surgeon Controlled Probe Surface Electrode Recording Kit Camera
- Model Identifier(s)
- 1895824 1895825 8225719 8225720 8225747 8225759 8225769 CPC16 CPCA16 CPCINDIA16 CPJ203 CPJ206 CPP500AUS CPP500EUR CPP500IND CPP500UK ECLC EPM3200 ITP916 LEA300 MDP201 MDPA201 MEP1001 MON19 NCCPU NCCPU-DE NCCPU-ES NCCPU-FR NCCPU-IT NCCPUE4 NRE1003 NRE1004 NSD2750 NWCPU NWCPUE4 OPM660 P216 P226 POC180 RSE1000 SPK1004 SRE1002 VC330
About this record
Access comprehensive regulatory information for Medtronic NIM-Eclipse SD 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 DE0013376 and owned by Medtronic Xomed. The device was registered on July 15, 2013.
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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