Taiwan FDA registration 10283c77a65c807fa203aeb4b5e02953

"Speed Test New" Cholesterol Test Strip (Unsterilized)

TW: "耐速測全新" 膽固醇試紙 (未滅菌)

Taiwan·Risk Class 1·Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd·Registered Sep 02, 2022 – Sep 02, 2027Active

Registration details

Analysis ID: 10283c77a65c807fa203aeb4b5e02953

Company information

Manufacturer: Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: KERNEL INT'L CORP.

Product details

Intended Use: Limited to the first level identification range of the "Cholesterol (Total) Test System (A.1175)" of the Measures for the Classification and Grading Management of Medical Equipment.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1175 Cholesterol (Total) Testing System
Import Information: 委託製造;; QMS/QSD;; 國產

Dates and status

Registration Date: Sep 02, 2022
Expiry Date: Sep 02, 2027

About this record

Access comprehensive regulatory information for "Speed Test New" Cholesterol Test Strip (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 10283c77a65c807fa203aeb4b5e02953 and manufactured by Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd. The authorized representative in Taiwan is KERNEL INT'L CORP..

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