Taiwan FDA registration 9c2ac53cac5576bb91620a7f328b1517

"Ostic" aspheric multifocal presbyopic intraocular lens

TW: "歐斯提克"非球面多焦點老花人工水晶體
Taiwan flagTaiwan·Risk Class 3·OPHTEC B.V.·Registered Jun 30, 2021 – Jun 30, 2026Expired
Registration details
Analysis ID
9c2ac53cac5576bb91620a7f328b1517
Customs Code
DHA05603404602
Company information
Manufacturer
OPHTEC B.V.
Manufacturer Country
Netherlands
Authorized Representative
BUTICON INTERNATIONAL CORPORATION
Product details
Intended Use
Details are as detailed as approved Chinese instructions
Product Type (Level 1)
M Ophthalmology
Product Type (Level 2)
M.3600 Artificial Crystal
Import Information
Safety monitoring;; import
Dates and status
Registration Date
Jun 30, 2021
Expiry Date
Jun 30, 2026
About this record

Access comprehensive regulatory information for "Ostic" aspheric multifocal presbyopic intraocular lens in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 9c2ac53cac5576bb91620a7f328b1517 and manufactured by OPHTEC B.V.. The authorized representative in Taiwan is BUTICON INTERNATIONAL CORPORATION.

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