Taiwan FDA registration ceef0c51fd48470e605a0c644b12f3e5
"Guanya" spine surgery instruments (sterilization)
TW: "冠亞"脊椎手術器械 (滅菌)
Taiwan·Risk Class 1·Guanya Biotechnology Co., Ltd. new store factory·Registered Nov 07, 2019 – Nov 07, 2029ActiveRegistration details
- Analysis ID
- ceef0c51fd48470e605a0c644b12f3e5
Company information
- Manufacturer
- Guanya Biotechnology Co., Ltd. new store factory
- Manufacturer Country
- Taiwan, Province of 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
- 國產;; QMS/QSD
Dates and status
- Registration Date
- Nov 07, 2019
- Expiry Date
- Nov 07, 2029
About this record
Access comprehensive regulatory information for "Guanya" spine surgery instruments (sterilization) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number ceef0c51fd48470e605a0c644b12f3e5 and manufactured by Guanya Biotechnology Co., Ltd. new store factory. The authorized representative in Taiwan is A-SPINE Asia Co., Ltd..
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