Taiwan FDA registration 9c09c29f852e9dd4ebdb1dffc60766e1

“BTL” RSWT non-invasive therapeutic device

TW: “比特樂”體外震波治療系統
Taiwan flagTaiwan·Risk Class 3·MD·BTL INDUSTRIES LIMITED;;BTL Industries JSC·Registered Apr 11, 2023 – Apr 11, 2028Active
Registration details
Analysis ID
9c09c29f852e9dd4ebdb1dffc60766e1
License Form
Ministry of Health Medical Device Import No. 036464
Customs Code
DHA05603646404
Company information
Manufacturer Country
Bulgaria;;United Kingdom
Authorized Representative
K&C MEDICAL CO., LTD.
Product details
Intended Use
Details are as detailed as approved Chinese instructions
Product Type (Level 1)
N Orthopedics
Product Type (Level 2)
N0001 Extracorporeal shock wave system for orthopedics
Import Information
Imported from abroad
Dates and status
Registration Date
Apr 11, 2023
Expiry Date
Apr 11, 2028
About this record

Access comprehensive regulatory information for “BTL” RSWT non-invasive therapeutic device in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 9c09c29f852e9dd4ebdb1dffc60766e1 and manufactured by BTL INDUSTRIES LIMITED;;BTL Industries JSC. The authorized representative in Taiwan is K&C MEDICAL CO., LTD..

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