Taiwan FDA registration 9437cc0affbeaeb7b5bdcd677b56679c

"Medeli" Saika handheld devices and accessories

TW: “美德力”賽卡手持裝置及配件

Taiwan·Risk Class 2·Sequel Special Products d.b.a Nissha Medical Technologies, Biomedical Innovations;; Mederi RF LLC·Registered Oct 10, 2019 – Oct 10, 2024Expired

Registration details

Analysis ID: 9437cc0affbeaeb7b5bdcd677b56679c
Customs Code: DHA05603297203

Company information

Manufacturer: Sequel Special Products d.b.a Nissha Medical Technologies, Biomedical Innovations;; Mederi RF LLC
Manufacturer Country: United States
Authorized Representative: Huizhong Co., Ltd

Product details

Intended Use: This product is used with RF host MDRF1 (model 177-5150) for the treatment of anal sphincter relaxation fecal incontinence, solid or liquid fecal incontinence at least once a week and patients who do not respond to other conservative treatments.
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: Contract manufacturing;; input

Dates and status

Registration Date: Oct 10, 2019
Expiry Date: Oct 10, 2024

About this record

Access comprehensive regulatory information for "Medeli" Saika handheld devices 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 9437cc0affbeaeb7b5bdcd677b56679c and manufactured by Sequel Special Products d.b.a Nissha Medical Technologies, Biomedical Innovations;; Mederi RF LLC. The authorized representative in Taiwan is Huizhong Co., Ltd.

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