Taiwan FDA registration eb8a0bb114e8c9a63a407ae956d74e33
"Zhiqi" Universal Osteotomy Guidance Plate System (Unsterilized)
TW: "智奇" 通用型截骨手術導引板系統 (未滅菌)
Taiwan·Risk Class 1·SHINEO TECHNOLOGY CO., LTD.·Registered Sep 16, 2019 – Sep 16, 2029ActiveRegistration details
- Analysis ID
- eb8a0bb114e8c9a63a407ae956d74e33
Company information
- Manufacturer
- SHINEO TECHNOLOGY CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- WIN YOUNNG CO., LTD.
Product details
- Intended Use
- Limited to the classification and grading management measures of medical equipment "Manual orthopedic surgical instruments (N.4540)" first grade identification range.
- Product Type (Level 1)
- N Orthopedics
- Product Type (Level 2)
- N.4540 手動式骨科手術器械
- Import Information
- QMS/QSD;; 國產;; 委託製造
Dates and status
- Registration Date
- Sep 16, 2019
- Expiry Date
- Sep 16, 2029
About this record
Access comprehensive regulatory information for "Zhiqi" Universal Osteotomy Guidance Plate System (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number eb8a0bb114e8c9a63a407ae956d74e33 and manufactured by SHINEO TECHNOLOGY CO., LTD.. The authorized representative in Taiwan is WIN YOUNNG CO., LTD..
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