Taiwan FDA registration a8eca6037a82d64a6cb87a64d73e37e1

Brighten Optix Corrective spectacle lens (Non-Sterile)

TW: 亨泰矯正鏡片 (未滅菌)

Taiwan·Risk Class 1·MD·BRIGHTEN OPTIX CORPORATION;;HONG KONG OPTICAL RX TECHNOLOGY CO., LTD.·Registered Feb 20, 2023 – Feb 20, 2028Active

Registration details

Analysis ID: a8eca6037a82d64a6cb87a64d73e37e1
License Form: Ministry of Health Medical Device Manufacturing No. 009809

Company information

Manufacturer: BRIGHTEN OPTIX CORPORATION;;HONG KONG OPTICAL RX TECHNOLOGY CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: BRIGHTEN OPTIX CORPORATION

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): M5844 corrective lenses
Import Information: Produced in Taiwan, China; Contract manufacturing

Dates and status

Registration Date: Feb 20, 2023
Expiry Date: Feb 20, 2028

About this record

Access comprehensive regulatory information for Brighten Optix Corrective spectacle lens (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 a8eca6037a82d64a6cb87a64d73e37e1 and manufactured by BRIGHTEN OPTIX CORPORATION;;HONG KONG OPTICAL RX TECHNOLOGY CO., LTD.. The authorized representative in Taiwan is BRIGHTEN OPTIX CORPORATION.

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