Taiwan FDA registration b4d057de86aeda2d88bc8a4aa7c6e811
"Shule" Limb Orthosis(Non-Sterile)
TW: "舒樂"肢體裝具(未滅菌)
Registration details
- Analysis ID
- b4d057de86aeda2d88bc8a4aa7c6e811
- License Form
- Ministry of Health Medical Device Land Transport Registration No. 001562
- Customs Code
- DHA08600156201
Company information
- Manufacturer
- NANJING SHULE PROSTHETICS ORTHOTICS LTD
- Manufacturer Country
- China
- Authorized Representative
- Heavy Maintenance Rehabilitation Products Co., Ltd
Product details
- Intended Use
- Limited to the first level recognition range of limb equipment (O.3475) of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- o Equipment for physical medicine
- Product Type (Level 2)
- O3475 Body Equipment
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 01, 2021
- Expiry Date
- Oct 31, 2027
About this record
Access comprehensive regulatory information for "Shule" Limb Orthosis(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 b4d057de86aeda2d88bc8a4aa7c6e811 and manufactured by NANJING SHULE PROSTHETICS ORTHOTICS LTD. The authorized representative in Taiwan is Heavy Maintenance Rehabilitation Products Co., Ltd.
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