Taiwan FDA registration 9449aaeb125c9eb8e0b4dc11838f81d9
"Niten" ophthalmic eye mask (not sterilized)
TW: "日滕" 眼科用眼罩 (未滅菌)
Taiwan·Risk Class 1·SHENGDEI TECHNOLOGY CO., LTD.·Registered Sep 19, 2019 – Sep 19, 2024ExpiredRegistration details
- Analysis ID
- 9449aaeb125c9eb8e0b4dc11838f81d9
Company information
- Manufacturer
- SHENGDEI TECHNOLOGY CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Riteng Biomedical Co., Ltd
Product details
- Intended Use
- Limited to the first level recognition range of ophthalmic eye masks (M.4750) of the classification and grading management measures for medical equipment.
- Product Type (Level 1)
- M Ophthalmology
- Product Type (Level 2)
- M.4750 Ophthalmic eye patches
- Import Information
- Domestic;; Contract manufacturing
Dates and status
- Registration Date
- Sep 19, 2019
- Expiry Date
- Sep 19, 2024
About this record
Access comprehensive regulatory information for "Niten" ophthalmic eye mask (not sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 9449aaeb125c9eb8e0b4dc11838f81d9 and manufactured by SHENGDEI TECHNOLOGY CO., LTD.. The authorized representative in Taiwan is Riteng Biomedical Co., Ltd.
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