Taiwan FDA registration 514383eb4f3c56662660b403abbcca1c
“NeuroDx” ShuntCheck III Detection System
TW: “紐洛德”桑德腦脊髓液分流檢測系統
Taiwan·Risk Class 2·MD·NeuroDx Development LLC·Registered Dec 13, 2017 – Dec 13, 2022ExpiredRegistration details
- Analysis ID
- 514383eb4f3c56662660b403abbcca1c
- License Form
- Ministry of Health Medical Device Import No. 030308
- Customs Code
- DHA05603030802
Company information
- Manufacturer
- NeuroDx Development LLC
- Manufacturer Country
- United States
- Authorized Representative
- MATECH HEALTHCARE CORPORATION
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- K Devices for neuroscience
- Product Type (Level 2)
- K5550 Central nervous system fluid shunt and its components
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 13, 2017
- Expiry Date
- Dec 13, 2022
About this record
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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