Taiwan FDA registration ff416d040e6fc7541686620900980a76

"Singular" positron/computed tomography system

TW: “奇異” 正子/電腦斷層掃瞄系統
Taiwan flagTaiwan·Risk Class 2·GE MEDICAL SYSTEMS ISRAEL-FUNCTIONAL IMAGING·Registered Oct 27, 2023 – Oct 27, 2028Active
Registration details
Analysis ID
ff416d040e6fc7541686620900980a76
Customs Code
DHAS5603663806
Company information
Manufacturer Country
Israel
Authorized Representative
GE MEDICAL SYSTEMS TAIWAN, LTD.
Product details
Intended Use
Details are as detailed as approved Chinese instructions
Product Type (Level 1)
P Radiology Science
Product Type (Level 2)
P.1200 Radiology CT system
Import Information
Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); The use of this device shall comply with the provisions of the "Administrative Measures for the Implementation or Use of Medical Devices for Specific Medical Technology Inspection and Testing". input
Dates and status
Registration Date
Oct 27, 2023
Expiry Date
Oct 27, 2028
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About this record

Access comprehensive regulatory information for "Singular" positron/computed tomography system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ff416d040e6fc7541686620900980a76 and manufactured by GE MEDICAL SYSTEMS ISRAEL-FUNCTIONAL IMAGING. The authorized representative in Taiwan is GE MEDICAL SYSTEMS TAIWAN, LTD..

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including GE MEDICAL SYSTEMS, GE MEDICAL SYSTEMS, LLC, and 5 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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