Taiwan FDA registration b947bb9adea5ca671fdae079bccc0b68

"Kemai" bipolar radio frequency electrocautery device

TW: “科脈”雙極射頻電燒裝置

Taiwan·Risk Class 2·Kelu Biotech Co., Ltd.;; Dalong Enterprise Co., Ltd·Registered Apr 11, 2024 – Apr 11, 2029Active

Registration details

Analysis ID: b947bb9adea5ca671fdae079bccc0b68

Company information

Manufacturer: Kelu Biotech Co., Ltd.;; Dalong Enterprise Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Clearmind Biomedical Inc.

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
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Apr 11, 2024
Expiry Date: Apr 11, 2029

About this record

Access comprehensive regulatory information for "Kemai" bipolar radio frequency electrocautery device in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b947bb9adea5ca671fdae079bccc0b68 and manufactured by Kelu Biotech Co., Ltd.;; Dalong Enterprise Co., Ltd. The authorized representative in Taiwan is Clearmind Biomedical Inc..

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