Taiwan FDA registration 4aec9c088e7e295f5bde870fa48b5434

"Kreisisch" the third generation of ultrasound system and accessories

TW: “克雷西施”歐萃芙茉第三代超音波系統及配件

Taiwan·Risk Class 2·Classys Inc.·Registered Jan 31, 2018 – Jan 31, 2028Active

Registration details

Analysis ID: 4aec9c088e7e295f5bde870fa48b5434
Customs Code: DHA05603069404

Company information

Manufacturer: Classys Inc.
Manufacturer Country: Korea, Republic of
Authorized Representative: UGINTECH CORPORATION

Product details

Intended Use: This product is a non-invasive skin treatment device suitable for: ‧Facial eyebrow lift, sagging chin lift (this product may damage nerves, do not apply to the chin and mandible edge). ‧Improve the firmness of the skin on the cheeks, lower abdomen and thighs.
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4590 Focused Ultrasound Stimulator
Import Information: Input;; 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.

Dates and status

Registration Date: Jan 31, 2018
Expiry Date: Jan 31, 2028

About this record

Access comprehensive regulatory information for "Kreisisch" the third generation of ultrasound system and accessories in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4aec9c088e7e295f5bde870fa48b5434 and manufactured by Classys Inc.. The authorized representative in Taiwan is UGINTECH CORPORATION.

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