Taiwan FDA registration 3814e934686e50f9dee490bbd9a5f0c3
“STABLE STEP”POWERSTEP Limb orthosis（Non-Sterile）
TW: “杰生”跑而步 肢體裝具（未滅菌）
Taiwan·Risk Class 1·MD·STABLE STEP, LLC·Registered Oct 01, 2021 – Oct 31, 2026ActiveRegistration details
- Analysis ID
- 3814e934686e50f9dee490bbd9a5f0c3
- License Form
- Ministry of Health Medical Device Import Registration No. 010370
- Customs Code
- DHA08401037003
Company information
- Manufacturer
- STABLE STEP, LLC
- Manufacturer Country
- United States
- Authorized Representative
- JSC BIOMECHANIC FOOTWEAR 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, 2026
About this record
Access comprehensive regulatory information for “STABLE STEP”POWERSTEP 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 3814e934686e50f9dee490bbd9a5f0c3 and manufactured by STABLE STEP, LLC. The authorized representative in Taiwan is JSC BIOMECHANIC FOOTWEAR LTD..
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