Taiwan FDA registration 2b3f7ba5512fb7a407de23b48a83cbe5
"Guanya" orthopedic surgical instruments (unsterilized)
TW: "冠亞"骨科手術器械(未滅菌)
Registration details
- Analysis ID
- 2b3f7ba5512fb7a407de23b48a83cbe5
- Customs Code
- DHA09600448102
Company information
- Manufacturer
- SHANDONG XINHUA HEALTHCARE INDUSTRY CO., LIMITED
- Manufacturer Country
- China
- Authorized Representative
- A-SPINE Asia 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
- Input;; Chinese goods
Dates and status
- Registration Date
- Apr 01, 2021
- Expiry Date
- Apr 01, 2026
About this record
Access comprehensive regulatory information for "Guanya" orthopedic surgical instruments (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2b3f7ba5512fb7a407de23b48a83cbe5 and manufactured by SHANDONG XINHUA HEALTHCARE INDUSTRY CO., LIMITED. The authorized representative in Taiwan is A-SPINE Asia Co., Ltd..
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