Taiwan FDA registration 59a6962ce8d962621637ada7768b7154

"Recorn" thulium fiber laser treatment system

TW: “瑞柯恩”銩光纖雷射治療系統

Taiwan·Risk Class 2·Shanghai Raykeen Laser Technology Co., Ltd.·Registered Jun 14, 2022 – Jun 14, 2027Active

Registration details

Analysis ID: 59a6962ce8d962621637ada7768b7154
Customs Code: DHA09200136706

Company information

Manufacturer: Shanghai Raykeen Laser Technology Co., Ltd.
Manufacturer Country: China
Authorized Representative: WISDOM UNION ENTERPRISE CO., LTD.

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4810 Lasers for general surgical, orthopaedic and dermatological use
Import Information: Chinese goods;; input

Dates and status

Registration Date: Jun 14, 2022
Expiry Date: Jun 14, 2027

About this record

Access comprehensive regulatory information for "Recorn" thulium fiber laser 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 59a6962ce8d962621637ada7768b7154 and manufactured by Shanghai Raykeen Laser Technology Co., Ltd.. The authorized representative in Taiwan is WISDOM UNION ENTERPRISE CO., LTD..

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