Taiwan FDA registration 7a36d7146d425332b78a41210a4210bb
Sunlus Mechanical walker (Non-Sterile)
TW: 三樂事 機械式助行器 (未滅菌)
Taiwan·Risk Class 1·MD·ST. YORK ENTERPRISE CO., LTD.·Registered Dec 12, 2016 – Dec 12, 2021ExpiredRegistration details
- Analysis ID
- 7a36d7146d425332b78a41210a4210bb
- License Form
- Ministry of Health Medical Device Manufacturing No. 006519
Company information
- Manufacturer
- ST. YORK ENTERPRISE CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- SUNLUS CO., LTD.
Product details
- Intended Use
- Limited to the scope of Grade 1 identification of "Mechanical Mobility Aids (O.3825)" under the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- o Equipment for physical medicine
- Product Type (Level 2)
- O3825 Mechanical Mobility Aid
- Import Information
- Produced in Taiwan, China; Contract manufacturing
Dates and status
- Registration Date
- Dec 12, 2016
- Expiry Date
- Dec 12, 2021
About this record
Access comprehensive regulatory information for Sunlus Mechanical walker (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 7a36d7146d425332b78a41210a4210bb and manufactured by ST. YORK ENTERPRISE CO., LTD.. The authorized representative in Taiwan is SUNLUS CO., LTD..
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