Taiwan FDA registration 857e193da9dd8c8f8f6434cf028ecc9c
"Purien Odika" automatic ophthalmic refractive machine (unsterilized)
TW: "彼連歐帝卡" 自動眼科驗光機 (未滅菌)
Taiwan·Risk Class 1·PlenOptika Europe, S.L.U.·Registered Aug 31, 2023 – Oct 31, 2025ExpiredRegistration details
- Analysis ID
- 857e193da9dd8c8f8f6434cf028ecc9c
- Customs Code
- DHA084a0021900
Company information
- Manufacturer
- PlenOptika Europe, S.L.U.
- Manufacturer Country
- Spain
- Authorized Representative
- TAIWAN OPTICAL CO., LTD.
Product details
- Intended Use
- Limited to the first level identification scope of the "Automatic Ophthalmic Refractive Machine (M.1760)" of the Measures for the Classification and Grading of Medical Equipment.
- Product Type (Level 1)
- M Ophthalmology
- Product Type (Level 2)
- M.1760 Automatic Ophthalmic Optical Machine
Dates and status
- Registration Date
- Aug 31, 2023
- Expiry Date
- Oct 31, 2025
About this record
Access comprehensive regulatory information for "Purien Odika" automatic ophthalmic refractive machine (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 857e193da9dd8c8f8f6434cf028ecc9c and manufactured by PlenOptika Europe, S.L.U.. The authorized representative in Taiwan is TAIWAN OPTICAL CO., LTD..
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