Taiwan FDA registration 5a44a24a0770fb53cdf24c1fbd521c2f
"Bole Crystal" Jinou treatment system
TW: “博樂晶”勁歐治療系統
Taiwan·Risk Class 2·POLLOGEN LTD.·Registered Apr 27, 2016 – Apr 27, 2026ExpiredRegistration details
- Analysis ID
- 5a44a24a0770fb53cdf24c1fbd521c2f
- Customs Code
- DHA05602838805
Company information
- Manufacturer
- POLLOGEN LTD.
- Manufacturer Country
- Israel
- Authorized Representative
- (Hong Kong) Lumenis Be (HK) Limited, Taiwan Branch
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- o Physical Medical Sciences;; I General, Plastic Surgery and Dermatology
- Product Type (Level 2)
- O.5300 Ultrasound diathermy treatment instrument;; I.4400 Cutting and hemostasis electric knives and accessories thereof
- Import Information
- The use of this device shall comply with the provisions of the "Administrative Measures for the Implementation or Use of Medical Devices for Specific Medical Technology Inspection and Testing". input
Dates and status
- Registration Date
- Apr 27, 2016
- Expiry Date
- Apr 27, 2026
About this record
Access comprehensive regulatory information for "Bole Crystal" Jinou treatment system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5a44a24a0770fb53cdf24c1fbd521c2f and manufactured by POLLOGEN LTD.. The authorized representative in Taiwan is (Hong Kong) Lumenis Be (HK) Limited, Taiwan Branch.
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