Taiwan FDA registration 3895760d6f5e7211713a3008a219ad46
"Bedaler" extracorporeal shock wave therapy system
TW: “倍達樂”體外震波治療系統
Taiwan·Risk Class 3·BTL Industries JSC;; BTL INDUSTRIES LIMITED·Registered Jun 24, 2021 – Jun 24, 2026ExpiredRegistration details
- Analysis ID
- 3895760d6f5e7211713a3008a219ad46
- Customs Code
- DHA05603468500
Company information
- Manufacturer
- BTL Industries JSC;; BTL INDUSTRIES LIMITED
- Manufacturer Country
- Bulgaria;;United Kingdom
- Authorized Representative
- BTL healthcare Taiwan limited company
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- N Orthopedics;; H Gastroenterology and Urology
- Product Type (Level 2)
- N.0001 骨科用體外震波系統;; H.0003 泌尿科用體外震波治療系統
- Import Information
- import
Dates and status
- Registration Date
- Jun 24, 2021
- Expiry Date
- Jun 24, 2026
About this record
Access comprehensive regulatory information for "Bedaler" extracorporeal shock wave therapy system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 3895760d6f5e7211713a3008a219ad46 and manufactured by BTL Industries JSC;; BTL INDUSTRIES LIMITED. The authorized representative in Taiwan is BTL healthcare Taiwan limited company.
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