Taiwan FDA registration 9549b0cb2f99e0717c34676651fe6b33
SOFTGUARDS Limb orthosis (Non-Sterile)
TW: "高禎" 肢體裝具 (未滅菌)
Taiwan·Risk Class 1·MD·KAO CHEN ENTERPRISE CO., LTD.·Registered Oct 01, 2021 – Oct 31, 2025ExpiredRegistration details
- Analysis ID
- 9549b0cb2f99e0717c34676651fe6b33
- License Form
- Ministry of Health Medical Device Manufacturing Registration No. 005585
Company information
- Manufacturer
- KAO CHEN ENTERPRISE CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- KAO CHEN ENTERPRISE CO., LTD.
Product details
- Intended Use
- Limited to the first level recognition range of limb equipment (O.3475) of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- o Equipment for physical medicine
- Product Type (Level 2)
- O3475 Body Equipment
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Oct 01, 2021
- Expiry Date
- Oct 31, 2025
About this record
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.
Free DatabasePowered by Pure Global AI89,000+ Devices