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“Shawen Dane” limb orthosis (Non-Sterile) - Taiwan Registration 43f293beffe2081c4255b24592e2b47d

Access comprehensive regulatory information for “Shawen Dane” limb orthosis (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 43f293beffe2081c4255b24592e2b47d and manufactured by Xiaodong Enterprise Limited. The authorized representative in Taiwan is Xiaodong Enterprise Limited.

This page provides complete technical specifications, regulatory compliance details. 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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43f293beffe2081c4255b24592e2b47d
Registration Details
Taiwan FDA Registration: 43f293beffe2081c4255b24592e2b47d
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Device Details

“Shawen Dane” limb orthosis (Non-Sterile)
TW: “小東”肢體裝具 (未滅菌)
Risk Class 1
MD

Registration Details

43f293beffe2081c4255b24592e2b47d

Ministry of Health Medical Device Manufacturing Registration No. 005517

Company Information

Taiwan, Province of China

Product Details

Limited to the first level recognition range of limb equipment (O.3475) of the Measures for the Administration of Medical Devices.

o Equipment for physical medicine

O3475 Body Equipment

Produced in Taiwan, China

Dates and Status

Oct 01, 2021

Oct 31, 2025