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SOFTGUARDS Limb orthosis (Non-Sterile) - Taiwan Registration 9549b0cb2f99e0717c34676651fe6b33

Access comprehensive regulatory information for SOFTGUARDS 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 9549b0cb2f99e0717c34676651fe6b33 and manufactured by KAO CHEN ENTERPRISE CO., LTD.. The authorized representative in Taiwan is KAO CHEN ENTERPRISE CO., LTD..

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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9549b0cb2f99e0717c34676651fe6b33
Registration Details
Taiwan FDA Registration: 9549b0cb2f99e0717c34676651fe6b33
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Device Details

SOFTGUARDS Limb orthosis (Non-Sterile)
TW: "้ซ˜็ฆŽ" ่‚ข้ซ”่ฃๅ…ท (ๆœชๆป…่Œ)
Risk Class 1
MD

Registration Details

9549b0cb2f99e0717c34676651fe6b33

Ministry of Health Medical Device Manufacturing Registration No. 005585

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