Taiwan FDA registration 5cd1e68b0b20544180056d363f381815

"Bedaler" high-frequency electromagnetic field system

TW: “倍達樂”高頻電磁場系統
Taiwan flagTaiwan·Risk Class 2·BTL Industries JSC;; BTL INDUSTRIES LIMITED·Registered Jul 28, 2021 – Jul 28, 2026Expired
Registration details
Analysis ID
5cd1e68b0b20544180056d363f381815
Customs Code
DHA05603425804
Company information
Manufacturer Country
Bulgaria;;United Kingdom
Authorized Representative
BTL healthcare Taiwan limited company
Product details
Intended Use
This product uses radio frequency to heat the treatment area to destroy subcutaneous fat cells, thereby reducing the thickness and body circumference of abdominal fat. In addition, this product triggers magnetic field stimulation, which causes abdominal muscle tightening.
Product Type (Level 1)
o Physical Medical Sciences;; I General, Plastic Surgery and Dermatology
Product Type (Level 2)
O.5850 Kinetic Muscle Stimulator;; I.9999 Miscellaneous
Import Information
import
Dates and status
Registration Date
Jul 28, 2021
Expiry Date
Jul 28, 2026
About this record

Access comprehensive regulatory information for "Bedaler" high-frequency electromagnetic field system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5cd1e68b0b20544180056d363f381815 and manufactured by BTL Industries JSC;; BTL INDUSTRIES LIMITED. The authorized representative in Taiwan is BTL healthcare Taiwan limited company.

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