Taiwan FDA registration 5440fc7e2bfe8e6779eb3116b1e28cbe

"3DISC" Optical Impression Systems for CAD/CAM (Non-Sterile)

TW: "三帝" CAD/CAM光學取模系統 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·MD·3D IMAGING& SIMULATION CORP. AMERICAS·Registered Oct 01, 2021 – Oct 31, 2025Expired
Registration details
Analysis ID
5440fc7e2bfe8e6779eb3116b1e28cbe
License Form
Ministry of Health Medical Device Import Registration No. 021526
Customs Code
DHA08402152606
Company information
Manufacturer Country
United States
Authorized Representative
GAIAMED COMPANY
Product details
Intended Use
Limited to the first level recognition range of CAD/CAM optical mold taking system (F.3661) for the management of medical equipment.
Product Type (Level 1)
F Dental devices
Product Type (Level 2)
F3661 CAD/CAM optical mold taking system
Import Information
Imported from abroad
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2025
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About this record

Access comprehensive regulatory information for "3DISC" Optical Impression Systems for CAD/CAM (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 5440fc7e2bfe8e6779eb3116b1e28cbe and manufactured by 3D IMAGING& SIMULATION CORP. AMERICAS. The authorized representative in Taiwan is GAIAMED COMPANY.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including 3D IMAGING& SIMULATION CORP. AMERICAS, and 1 recent registrations in the same category. 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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