Taiwan FDA registration 744a527819136813bd6501468d0f6271

"NDAX" corrective lenses (unsterilized)

TW: "恩戴適" 矯正鏡片 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·En Dai Shi Co., Ltd.;; Singapore Sunsky Technology Co., Ltd. Taiwan Branch Taoyuan Factory·Registered Nov 08, 2023 – Nov 08, 2028Active
Registration details
Analysis ID
744a527819136813bd6501468d0f6271
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
OWNDAYS TAIWAN LTD.
Product details
Intended Use
Limited to the first level identification scope of the "corrective lenses (M.5844)" of the Measures for the Classification and Grading of Medical Equipment.
Product Type (Level 1)
M Ophthalmology
Product Type (Level 2)
M.5844 corrective lenses
Import Information
Domestic;; Contract manufacturing
Dates and status
Registration Date
Nov 08, 2023
Expiry Date
Nov 08, 2028
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About this record

Access comprehensive regulatory information for "NDAX" corrective lenses (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 744a527819136813bd6501468d0f6271 and manufactured by En Dai Shi Co., Ltd.;; Singapore Sunsky Technology Co., Ltd. Taiwan Branch Taoyuan Factory. The authorized representative in Taiwan is OWNDAYS TAIWAN LTD..

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including CENTRAL LABORATORY LTD., TREND OPTICAL LENS PTE. LTD. TAIWAN BRANCH (SINGAPORE), and 5 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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