Taiwan FDA registration 47d03f3c66365265972cc6c94d771335

Grey Berg Diamond, Diaplastic Cornea Night Wear Contact Lenses

TW: 葛瑞詩博視頓晶鑽角膜塑型夜戴型隱形眼鏡

Taiwan·Risk Class 3·Metro Optics, Inc·Registered Dec 20, 2011 – Dec 20, 2026Active

Registration details

Analysis ID: 47d03f3c66365265972cc6c94d771335
Customs Code: DHA00602322103

Company information

Manufacturer: Metro Optics, Inc
Manufacturer Country: United States
Authorized Representative: OPTACT INTERNATIONAL CO., LTD.

Product details

Intended Use: "Grey Berg Diamond Diaphragmatic Night Contact Lenses" is suitable for eyes without eye disease to reduce myopia. This lens is a night wear, limited to 12 years old (including 12 years old) and above, suitable for myopia below 5.00D, astigmatism -1.50D or less eyes, in order to temporarily reduce the degree of myopia, this lens can only be disinfected with a chemical disinfection system. Performance changes: As detailed in the Chinese copy of the imitation order (the original 100.12.28 approved copy of the imitation and label approval will be recycled and invalidated). "Gray Berg Diamond Diamond Orthokeratology Night Wear Contact Lenses" is suitable for eyes without eye diseases to reduce myopia. These lenses are night-worn and can only be used by ages 9 and older. 9 years old ~ 12 years old, suitable for myopia -4.0D, astigmatism -1.50D or less. When 12 years old or older, it is suitable for myopia -5.0D astigmatism -1.50 D or less. In order to temporarily reduce the degree of myopia, this lens can only be disinfected with a chemical disinfection system.
Product Type (Level 1): M Ophthalmology
Product Type (Level 2): M.5916 硬式透氣隱形眼鏡
Import Information: import

Dates and status

Registration Date: Dec 20, 2011
Expiry Date: Dec 20, 2026

About this record

Access comprehensive regulatory information for Grey Berg Diamond, Diaplastic Cornea Night Wear Contact Lenses in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 47d03f3c66365265972cc6c94d771335 and manufactured by Metro Optics, Inc. The authorized representative in Taiwan is OPTACT INTERNATIONAL CO., LTD..

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