Taiwan FDA registration bc8a1bfcf79c2e0eba4a01fca5c56775
"Biodex" Mechanical walker (Non-Sterile)
TW: "巴德斯" 機械式助行器(未滅菌)
Taiwan·Risk Class 1·MD·BIODEX MEDICAL SYSTEMS, INC.·Registered Jul 23, 2020 – Jul 23, 2025ExpiredRegistration details
- Analysis ID
- bc8a1bfcf79c2e0eba4a01fca5c56775
- License Form
- Ministry of Health Medical Device Import No. 021775
- Customs Code
- DHA09402177500
Company information
- Manufacturer
- BIODEX MEDICAL SYSTEMS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- AMPLE MEDICAL INSTRUMENTS 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
- Imported from abroad
Dates and status
- Registration Date
- Jul 23, 2020
- Expiry Date
- Jul 23, 2025
About this record
Access comprehensive regulatory information for "Biodex" 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 bc8a1bfcf79c2e0eba4a01fca5c56775 and manufactured by BIODEX MEDICAL SYSTEMS, INC.. The authorized representative in Taiwan is AMPLE MEDICAL INSTRUMENTS CO., LTD..
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