Taiwan FDA registration 305edd77338b8ed21340708180d87a90

Hi-X corrective spectacle lens (NON-sterile)

TW: 翡翠矯正鏡片 (未滅菌)

Taiwan·Risk Class 1·MD·Malaysia Merchant Lomi Co., Ltd. Taiwan Branch·Registered Dec 13, 2016 – Dec 13, 2021Expired

Registration details

Analysis ID: 305edd77338b8ed21340708180d87a90
License Form: Ministry of Health Medical Device Manufacturing No. 006521

Company information

Manufacturer: Malaysia Merchant Lomi Co., Ltd. Taiwan Branch
Manufacturer Country: Taiwan, Province of China
Authorized Representative: SHIH HENG OPTICAL PTE. LTD. TAIWAN BRANCH (SINGAPORE)

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Corrective Lenses (M.5844)".
Product Type (Level 1): M Ophthalmic devices
Product Type (Level 2): M5844 corrective lenses
Import Information: Produced in Taiwan, China; Contract manufacturing

Dates and status

Registration Date: Dec 13, 2016
Expiry Date: Dec 13, 2021

About this record

Access comprehensive regulatory information for Hi-X 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 305edd77338b8ed21340708180d87a90 and manufactured by Malaysia Merchant Lomi Co., Ltd. Taiwan Branch. The authorized representative in Taiwan is SHIH HENG OPTICAL PTE. LTD. TAIWAN BRANCH (SINGAPORE).

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