Taiwan FDA registration 0df993b1baa57c9a3e1496c18290fdce
"Bitel" high-intensity laser
TW: “比特爾”高強度雷射
Taiwan·Risk Class 2·BTL Industries JSC;; BTL INDUSTRIES LIMITED·Registered Dec 24, 2021 – Dec 24, 2026ActiveRegistration details
- Analysis ID
- 0df993b1baa57c9a3e1496c18290fdce
- Customs Code
- DHA05603478909
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
- This product is a non-invasive therapeutic device designed to emit the energy of infrared light to locally stimulate biological tissues. This tissue stimulation promotes accelerated healing of local wounds and pain relief. It can be used for pain relief caused by various muscle, tendon or joint lesions.
- Product Type (Level 1)
- o Physical Medical Sciences;; I General, Plastic Surgery and Dermatology
- Product Type (Level 2)
- O.5500 Infrared lamp;; I.4810 Lasers for general surgical, orthopaedic and dermatological use
- Import Information
- import
Dates and status
- Registration Date
- Dec 24, 2021
- Expiry Date
- Dec 24, 2026
About this record
Access comprehensive regulatory information for "Bitel" high-intensity laser in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0df993b1baa57c9a3e1496c18290fdce and manufactured by BTL Industries JSC;; BTL INDUSTRIES LIMITED. The authorized representative in Taiwan is BTL healthcare Taiwan limited company.
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