Taiwan FDA registration 1df508cbf32b0fa718bae8d740ae58bf
"Rekai" ophthalmic refractive machine (unsterilized)
TW: "瑞凱" 眼科用驗光機 (未滅菌)
Taiwan·Risk Class 1·REICHERT, INC.·Registered Sep 19, 2016 – Sep 19, 2021CancelledRegistration details
- Analysis ID
- 1df508cbf32b0fa718bae8d740ae58bf
- Customs Code
- DHA09401700600
Company information
- Manufacturer
- REICHERT, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TAIWAN HWA IN ENTERPRISE CO., LTD.
Product details
- Intended Use
- Limited to the first level recognition range of ophthalmic optometry machine (M.1760) of the management measures for medical equipment.
- Product Type (Level 1)
- M Ophthalmology
- Product Type (Level 2)
- M.1760 Automatic Ophthalmic Optical Machine
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Sep 19, 2016
- Expiry Date
- Sep 19, 2021
- Cancellation Date
- Sep 08, 2023
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for "Rekai" 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 1df508cbf32b0fa718bae8d740ae58bf and manufactured by REICHERT, INC.. The authorized representative in Taiwan is TAIWAN HWA IN ENTERPRISE CO., LTD..
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