Taiwan FDA registration 99e1853223db1e701b4b0d00a1688e8b

“OPHTEC” PRECIZON Monofocal Intraocular Lens

TW: “歐斯提克”精準型單焦點人工水晶體
Taiwan flagTaiwan·Risk Class 3·MD·OPHTEC B.V.·Registered Oct 23, 2015 – Oct 23, 2025Expired
Registration details
Analysis ID
99e1853223db1e701b4b0d00a1688e8b
License Form
Ministry of Health Medical Device Import No. 027767
Customs Code
DHA05602776708
Company information
Manufacturer
OPHTEC B.V.
Manufacturer Country
Netherlands
Authorized Representative
BUTICON INTERNATIONAL CORPORATION
Product details
Intended Use
For details, it is Chinese approved copy of the imitation order
Product Type (Level 1)
M Ophthalmic devices
Product Type (Level 2)
M3600 intraocular lens
Import Information
Imported from abroad
Dates and status
Registration Date
Oct 23, 2015
Expiry Date
Oct 23, 2025
About this record

Access comprehensive regulatory information for “OPHTEC” PRECIZON Monofocal 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 99e1853223db1e701b4b0d00a1688e8b and manufactured by OPHTEC B.V.. The authorized representative in Taiwan is BUTICON INTERNATIONAL CORPORATION.

This page provides complete technical specifications, regulatory compliance details. 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.

Free DatabasePowered by Pure Global AI89,000+ Devices