Taiwan FDA registration 4a9dcf81024eed5e94446020d3eb63cd

"Teh Sen" External assembled lower limb prosthesis (Non-Sterile)

TW: "德森" 體外組裝下肢義肢 (未滅菌)

Taiwan·Risk Class 1·MD·TEH SEN TECHNOLOGY INC.·Registered Jun 18, 2020 – Jun 18, 2025Expired

Registration details

Analysis ID: 4a9dcf81024eed5e94446020d3eb63cd
License Form: Ministry of Health Medical Device Manufacturing No. 008398

Company information

Manufacturer: TEH SEN TECHNOLOGY INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: TEH SEN TECHNOLOGY INC.

Product details

Intended Use: Limited to the first level recognition range of the in vitro assembly of lower limb prosthetics (O.3500) in the management measures for medical devices.
Product Type (Level 1): o Equipment for physical medicine
Product Type (Level 2): O3500 Lower limb prosthesis assembled in vitro
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Jun 18, 2020
Expiry Date: Jun 18, 2025

About this record

Access comprehensive regulatory information for "Teh Sen" External assembled lower limb prosthesis (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 4a9dcf81024eed5e94446020d3eb63cd and manufactured by TEH SEN TECHNOLOGY INC.. The authorized representative in Taiwan is TEH SEN TECHNOLOGY INC..

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.