Taiwan FDA registration e9eed2194d824054ad1a6314dde0d735
"Ostik" IOL guide (sterilization)
TW: "歐斯提克" 人工水晶體導引器 (滅菌)
Taiwan·Risk Class 1·OPHTEC B.V.·Registered Jun 29, 2015 – Jun 29, 2025ExpiredRegistration details
- Analysis ID
- e9eed2194d824054ad1a6314dde0d735
- Customs Code
- DHA09401539106
Company information
- Manufacturer
- OPHTEC B.V.
- Manufacturer Country
- Netherlands
- Authorized Representative
- BUTICON INTERNATIONAL CORPORATION
Product details
- Intended Use
- Limited to the first level identification range of "intraocular lens guide (M.4300)" of the Classification and Grading Management Measures for Medical Equipment.
- Product Type (Level 1)
- M Ophthalmology
- Product Type (Level 2)
- M.4300 Artificial crystal body inducer
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Jun 29, 2015
- Expiry Date
- Jun 29, 2025
About this record
Access comprehensive regulatory information for "Ostik" IOL guide (sterilization) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number e9eed2194d824054ad1a6314dde0d735 and manufactured by OPHTEC B.V.. The authorized representative in Taiwan is BUTICON INTERNATIONAL CORPORATION.
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