Taiwan FDA registration b9961c7233e13f2ab362759ac1bdd6e3

"Align Dental 3D Digital Scanner" (Unsterilized)

TW: "愛齊" 牙科3D數位掃描機 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·Align Technology Ltd.·Registered Oct 01, 2021 – Oct 31, 2026Active
Registration details
Analysis ID
b9961c7233e13f2ab362759ac1bdd6e3
Customs Code
DHA08401694404
Company information
Manufacturer Country
Israel
Authorized Representative
Invisalign Taiwan Limited
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
Import Information
Input;; QMS/QSD
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2026
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About this record

Access comprehensive regulatory information for "Align Dental 3D Digital Scanner" (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b9961c7233e13f2ab362759ac1bdd6e3 and manufactured by Align Technology Ltd.. The authorized representative in Taiwan is Invisalign Taiwan Limited.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including ALIGN TECHNOLOGY LTD., 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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