Taiwan FDA registration 97ee9e6f07fefcfc510656fd23fc95d8
“SmartLoc” Percutaneous Spinal Fixation System
TW: “史麥特”經皮脊椎後方固定系統
Taiwan·Risk Class 2·MD·Guanya Biotechnology Co., Ltd. new store factory·Registered Feb 05, 2016 – Feb 05, 2026ExpiredRegistration details
- Analysis ID
- 97ee9e6f07fefcfc510656fd23fc95d8
- License Form
- Ministry of Health Medical Device Manufacturing No. 005260
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
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- N Orthopedic devices
- Product Type (Level 2)
- N3070 Pedicle screw system
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Feb 05, 2016
- Expiry Date
- Feb 05, 2026
About this record
Access comprehensive regulatory information for “SmartLoc” Percutaneous Spinal Fixation System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 97ee9e6f07fefcfc510656fd23fc95d8 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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