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Compumedics Neuroscan SynAmps2 - HSA Registration DE0018705

Access comprehensive regulatory information for Compumedics Neuroscan SynAmps2 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018705 and owned by Compumedics USA, Inc. The device was registered on November 04, 2016.

This page provides complete registration details including product owner information, registrant details, 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
DE0018705
Compumedics Neuroscan SynAmps2
HSA Registration Number: DE0018705
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Product Description

The SynAmps2 system is intended for measuring recording of the electrical activity of a patient;s brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP Registration in the research environment. The System is intended to be used by qualified trained EEG technologists and or physicians. The data acquired must be interpreted by qualified physicians

Device Classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0018705
Registration Date
November 04, 2016
Retention Due Date
November 03, 2025
Product Owner
Short Name
Compumedics USA, Inc
Address
5015 West WT Harris Blvd, Suite E, Charlotte, NC 28269, UNITED STATES
Registrant
Address
221 HENDERSON ROAD, HENDERSON BUILDING, #08-12, SINGAPORE 159557
Model Information
Model Name(s)
Headbox 64-channel System Unit Power Unit SynAmp2 Curry Software Quik cap 64ch small Quik Cap 64ch Medium Quik Cap 64ch large Quik Cap 128Ch Large Quik Cap 128Ch Medium Quik Cap 128Ch small
Model Identifier(s)
00080460 00080530 00081220 8050 9138-0001-01 96050254 96050255 96050256 96050266 96050267 96050271