Taiwan FDA registration 53618e94094e8b0f17c6fd1ba0bc6197

"Xuda" CAD/CAM optical mold taking system (unsterilized)

TW: "旭達" CAD/CAM光學取模系統 (未滅菌)

Taiwan·Risk Class 1·SHINING 3D TECH CO., LTD.·Registered Feb 26, 2022 – Oct 31, 2025Expired

Registration details

Analysis ID: 53618e94094e8b0f17c6fd1ba0bc6197
Customs Code: DHA086a0004305

Company information

Manufacturer: SHINING 3D TECH CO., LTD.
Manufacturer Country: China
Authorized Representative: SMILDEN BIOTECHNOLOGY CO., LTD.

Product details

Intended Use: Limited to the classification and grading management method of medical equipment, CAD/CAM optical mold taking system (F.3661) first level recognition range.
Product Type (Level 1): F Dentistry
Product Type (Level 2): F.3661 CAD/CAM光學取模系統

Dates and status

Registration Date: Feb 26, 2022
Expiry Date: Oct 31, 2025

About this record

Access comprehensive regulatory information for "Xuda" CAD/CAM optical mold taking system (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 53618e94094e8b0f17c6fd1ba0bc6197 and manufactured by SHINING 3D TECH CO., LTD.. The authorized representative in Taiwan is SMILDEN BIOTECHNOLOGY 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.