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Medtronic NIM-Neuro 3.0 System - HSA Registration DE0012690

Access comprehensive regulatory information for Medtronic NIM-Neuro 3.0 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 DE0012690 and owned by Medtronic Xomed. The device was registered on April 02, 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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CLASS B
DE0012690
Medtronic NIM-Neuro 3.0 System
HSA Registration Number: DE0012690
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Product Description

Intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. The APS™electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0012690
Registration Date
April 02, 2013
Change Notification Approval Date
April 29, 2019
Retention Due Date
April 01, 2026
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)
Neurotologic Stimulus Dissection instrument Case Stimulus Dissection Curved needle Stimulus Dissection Elevator Stimuls Dissection Ring Dissector Stimuls Dissection Ring Dissector Stimulus Disection instrument/Storage Case Sickle Knife 90 degress Hook Large Crabtree Stimuls Dissection Ring Dissector Stimulus Dissection Ring Dissector Stimulus Dissection Cable Neruotologic Stimulus Dissection Right Angle Pick Neruotologic Stimulus Dissection Right Angle Pick Neurotologica stimulus dissedction curved needle Neurotological stimulus Dissection Duckbill Elevator Neurotological stimulus Dissection Duckbill Elevator Neurotologic Stimulus Dissection Round Knife Neurotologic Stimulus Dissection Round Knife Neurotologic Stimulus Dissection Round Knife Neurotologic Stimulus Disssection Raspatory Neurotologic Stimulus Disssection Raspatory Neurotologic Stimulus Disssection Raspatory Neurotologic Stimulus Disssection Raspatory Neurotologic Stimulus Disssection Raspatory Neurotologic Stimulus Dissection Raspattory PROBE 8220300 NIM MUTING DETECTOR MUTING PROBE 8220325 NIM HANDLE 8225051 10PK MONOPOLAR PROBE PROBE 8225101 5PK STD PRASS FLUSH TIP PROBE 8225103 5PK SLIM PRASS FLUSH TIP PROBE 8225105 10PK PRASS MONO SLIM PROBE 8225110 10PK PRASS MONO STD PROBE 8225251 5PK YINGLING MONO STIM PROBE 8225275 BALL TIP 1MM PROBE 8225276 BALL TIP 2.3MM PROBE 8225277 10PK BALL TIP 1MM PROBE 8225278 10PK BALL TIP 2.3MM PROBE 8225351 5PK KARTUSH CONCEN BIPOL PROBE 8225401 5PK KARTUSH SIDE BY SIDE PROBE 8225451 5PK PRASS BIPOL STIMULATOR PROBE 8225825 3PK INCREMT BALL TIP 1MM PROBE 8225825 3PK INCREMT STD PRASS TIP HOOKWIRE 8226326 1SET PAIRED ELECTRODE 8226626 6PK EMG SNGL HOOKWIRE ELECTRODE 8227103 SUBDERM NEEDLE SET ELECTRODE 8227130 25PK NEEDLE 1.5MM RED ELECTRODE 8227131 25PK NEEDLE 1.5MM YELW ELECTRODE 8227132 25PK NEEDLE 1.5MM BLUE ELECTRODE 8227133 25PK NEEDLE 1.5MM VIOL ELECTRODE 8227134 25PK NEEDLE 1.5MM GRN ELECTRODE 8227135 25PK NEEDLE 1.5MM BLK ELECTRODE 8227136 25PK NEEDLE 1.5MM ORAN ELECTRODE 8227137 25PK NEEDLE 1.5MM WHT ELECTRODE 8227138 25PK NEEDLE 1.5MM BRWN ELECTRODE 8227139 25PK EEG NEEDLE 1.5MM ELECTRODE 8227140 25PK EEG NEEDLE 1.5MM ELECTRODE 8227141 25PK EEG NEEDLE 1.5MM ELECTRODE 8227301 5SET PRASS PAIRED 25MM ELECTRODE 8227304 5SET PRASS PAIRED 18MM ELECTRODE 8227307 5SET PRASS PAIRED 38MM ELECTRODE 8227410 PAIRED 2 CHANNEL SET ELECTRODE 8227411 PAIRED 4 CHANNEL SET ELECTRODE 8227412 PAIRED 8 CHANNEL SET ELECTRODE 8227414 5SET PRASS PAIRED 2CH ELECTRODE 8227415 5SET PRASS PAIRED 4CH ELECTRODE 8227418 5PK PRASS PAIRED 2CH ELECTRODE 8227419 5PK PRASS PAIRED 4CH ELECTRODE 8227421 TWISTED PAIR SET 4CH ELECTRODE 8227422 TWISTED PAIR SET 8CH ELECTRODE 8227450 5PK PRD SUBDERMAL GRAY ELECTRODE 8227465 25PK PAIRED MIXED ELECTRODE 8227466 25PK PAIRED ELECTRODE 8227500 5SET PRASS PAIRED 18MM ELECTRODE 8227505 5SET PRASS PAIRED 25MM ELECTRODE 8227510 5SET PRASS PAIRED 18MM ELECTRODE 8227515 5SET PRASS PAIRED 25MM ELECTRODE 8228052 APS 2MM ELECTRODE 8228053 APS 3MM ENDOTRACH TUBE 8229306 NIM EMG 6MM REINF ENDOTRACH TUBE 8229307 NIM EMG 7MM REINF ENDOTRACH TUBE 8229308 NIM EMG 8MM REINF ENDOTRACH TUBE 8229506 CONTACT EMG 6MM ENDOTRACH TUBE 8229507 CONTACT EMG 7MM ENDOTRACH TUBE 8229508 CONTACT EMG 8MM EMG TUBE 8229705 5.0 MM ID EMG TUBE 8229706 6.0 MM ID EMG TUBE 8229707 7.0 MM ID EMG TUBE 8229708 8.0 MM ID EMG TUBE 8229709 9.0 MM ID EMG TUBE 8229735 3PK 5.0 MM ID EMG TUBE 8229736 3PK 6.0 MM ID EMG TUBE 8229737 3PK 7.0 MM ID EMG TUBE 8229738 3PK 8.0 MM ID EMG TUBE 8229739 3PK 9.0 MM ID ENDOTRACH TUBE 8229960 5PK 6MM EMG FLEX ENDOTRACH TUBE 8229965 5PK 6.5MM EMG FLX ENDOTRACH TUBE 8229970 5PK 7MM EMG FLEX ENDOTRACH TUBE 8229975 5PK 7.5MM EMG FLX ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX ENDOTRACH TUBE 8229985 5PK 8.5MM EMG FLX NIM 2.0 Console Fuse Kit, 4AMP NIM-Neuro 2.0 Patient Interface NIM-Neuro 2.0 Patient Simulator MINI SCREEN 8253010 SURGEON CABLE 8253015 MICROSCOPE CART 8253020 NIM 3.0 SYSTEM POWER SUPPLY 8253025 NIM PRINTER CABLE 8253028 USB 2 METER POWER CORD 8253029 NIM 3.0 PRINTER CASE 8253035 NIM 3.0 STORAGE BIOMED TEST KIT 8253040 NIM 3.0 UNIV CD 8253050E RESP/NEURO 3.0 IFU EN,RU HANDSWITCH 8253054 APS NERVE ELECTRODE CABLE 8253080 MINI SCREEN ADAPTOR KIT 8253085 NIM 3.0 VID/AUD REC NIM-Neuro 3.0 Mainframe INTL PATIENT INTERFACE 8253410 NIM NEURO 3.0 PATIENT SIMULATOR 8253600 NIM 3.0 UNIV
Model Identifier(s)
1352396 1352401 1352402 1352403 1352404 1352407 1352408 1352409 1352410 1352412 1352413 1352415 1353401 1353402 1353403 1353404 1353405 1353406 1353407 1353408 1353409 1353410 1353411 1353412 1353413 1353414 8220300 8220325 8225051 8225101 8225103 8225105 8225110 8225251 8225275 8225276 8225277 8225278 8225351 8225401 8225451 8225490 8225825 8226326 8226626 8227103 8227130 8227131 8227132 8227133 8227134 8227135 8227136 8227137 8227138 8227139 8227140 8227141 8227301 8227304 8227307 8227410 8227411 8227412 8227414 8227415 8227418 8227419 8227421 8227422 8227450 8227465 8227466 8227500 8227505 8227510 8227515 8228052 8228053 8229306 8229307 8229308 8229506 8229507 8229508 8229705 8229706 8229707 8229708 8229709 8229735 8229736 8229737 8229738 8229739 8229960 8229965 8229970 8229975 8229980 8229985 8250616 8252410 8252411 8253010 8253015 8253020 8253025 8253028 8253029 8253035 8253040 8253050E 8253054 8253080 8253085 8253402 8253410 8253600