“NeuroDx” ShuntCheck III Detection System - Taiwan Registration 514383eb4f3c56662660b403abbcca1c
Access comprehensive regulatory information for “NeuroDx” ShuntCheck III Detection System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 514383eb4f3c56662660b403abbcca1c and manufactured by NeuroDx Development LLC. The authorized representative in Taiwan is MATECH HEALTHCARE CORPORATION.
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Device Details
Registration Details
514383eb4f3c56662660b403abbcca1c
Ministry of Health Medical Device Import No. 030308
DHA05603030802
Product Details
This product can assist in detecting the shunt of a shunt device implanted with cerebrospinal fluid (CSF). This product contains a Micro-Pumper, an accessory that facilitates flow during the testing of the diverter device in the event that the diverter is suspected to be temporarily free of flow. This product cannot diagnose normal or malfunctioning CSF shunt devices alone. Clinical diagnosis of normal or malfunctioning cerebrospinal fluid shunt devices should only be made by qualified neurosurgeons who are fully aware of the shunt information of this product.
K Devices for neuroscience
K5550 Central nervous system fluid shunt and its components
Imported from abroad
Dates and Status
Dec 13, 2017
Dec 13, 2022