Taiwan FDA registration 8a6e3c06dad61a08ff45e8328d6a4a19

"Axon" electronic proximity therapy system

TW: “艾克孚”艾克生電子近接治療系統
Taiwan flagTaiwan·Risk Class 2·Xoft, a subsidiary of iCAD·Registered Jan 03, 2013 – Jan 03, 2028Active
Registration details
Analysis ID
8a6e3c06dad61a08ff45e8328d6a4a19
Customs Code
DHAS0602427908
Company information
Manufacturer Country
United States
Authorized Representative
Meide Medical Devices Co., Ltd
Product details
Intended Use
For details, it is Chinese approved copy of the imitation order
Product Type (Level 1)
P Radiology Science
Product Type (Level 2)
P.5900 X光放射線治療系統
Import Information
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;; Consent letter must be attached to the import (consent from the Atomic Energy Commission must be obtained for each import)
Dates and status
Registration Date
Jan 03, 2013
Expiry Date
Jan 03, 2028
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About this record

Access comprehensive regulatory information for "Axon" electronic proximity therapy system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8a6e3c06dad61a08ff45e8328d6a4a19 and manufactured by Xoft, a subsidiary of iCAD. The authorized representative in Taiwan is Meide Medical Devices Co., Ltd.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including XOFT, INC., and 1 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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