Taiwan FDA registration afb73f92a90b9e8004d755999596a93a
"Waterske" Hand Ophthalmic Surgical Device (Sterilization)
TW: "沃特斯克" 手動式眼科手術器械 (滅菌)
Taiwan·Risk Class 1·Vortex Surgical, Inc·Registered Jan 12, 2024 – Jan 12, 2029ActiveRegistration details
- Analysis ID
- afb73f92a90b9e8004d755999596a93a
- Customs Code
- DHA09402336004
Company information
- Manufacturer
- Vortex Surgical, Inc
- Manufacturer Country
- United States
- Authorized Representative
- CRYSTALVISION CO., LTD.
Product details
- Intended Use
- Limited to the first level identification scope of the "Manual Ophthalmic Surgical Instruments (M.4350)" of the Measures for the Classification and Grading of Medical Equipment.
- Product Type (Level 1)
- M Ophthalmology
- Product Type (Level 2)
- M.4350 手動式眼科手術器械
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jan 12, 2024
- Expiry Date
- Jan 12, 2029
About this record
Access comprehensive regulatory information for "Waterske" Hand Ophthalmic Surgical Device (Sterilization) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number afb73f92a90b9e8004d755999596a93a and manufactured by Vortex Surgical, Inc. The authorized representative in Taiwan is CRYSTALVISION CO., LTD..
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