Taiwan FDA registration 411ad689665d8f6f98ae5be77119fd79
"Owei" Solis ophthalmic optical homology tomography system and its accessories
TW: “歐威”索力斯眼科用光學同調斷層掃描系統及其配件
Taiwan·Risk Class 2·Mingda Medical Technology Co., Ltd.;; Optovue Inc.·Registered Mar 01, 2023 – Mar 01, 2028ActiveRegistration details
- Analysis ID
- 411ad689665d8f6f98ae5be77119fd79
- Customs Code
- DHA05500782005
Company information
- Manufacturer Country
- Taiwan, Province of China;;United States
- Authorized Representative
- CLINICO INC.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- M Ophthalmology
- Product Type (Level 2)
- M.1570 Fundus Mirrors
- Import Information
- Contract manufacturing;; Commissioned domestic manufacturing abroad, and then imported from abroad; Domestic
Dates and status
- Registration Date
- Mar 01, 2023
- Expiry Date
- Mar 01, 2028
About this record
Access comprehensive regulatory information for "Owei" Solis ophthalmic optical homology tomography system and its accessories in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 411ad689665d8f6f98ae5be77119fd79 and manufactured by Mingda Medical Technology Co., Ltd.;; Optovue Inc.. The authorized representative in Taiwan is CLINICO INC..
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