Taiwan FDA registration b4aea0a11d09f3e040660e2d9ca8a99e
"Kutra" Genesis High System
TW: “酷特拉”創世高系統
Taiwan·Risk Class 2·Johari Digital Healthcare Ltd.;; CUTERA, INC.·Registered Jun 15, 2022 – Jun 15, 2027ActiveRegistration details
- Analysis ID
- b4aea0a11d09f3e040660e2d9ca8a99e
- Customs Code
- DHA05603549500
Company information
- Manufacturer
- Johari Digital Healthcare Ltd.;; CUTERA, INC.
- Manufacturer Country
- United States;;India
- Authorized Representative
- EMERGO TAIWAN LIMITED
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.4400 Cutting and hemostasis electric knives and accessories thereof; I.0001 High-density energy current eliminator
- Import Information
- Safety monitoring;; import
Dates and status
- Registration Date
- Jun 15, 2022
- Expiry Date
- Jun 15, 2027
About this record
Access comprehensive regulatory information for "Kutra" Genesis High System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b4aea0a11d09f3e040660e2d9ca8a99e and manufactured by Johari Digital Healthcare Ltd.;; CUTERA, INC.. The authorized representative in Taiwan is EMERGO TAIWAN LIMITED.
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