Taiwan FDA registration 416b2e7197e357948151b9dd01e842c0

"Kono" Cholesterol Monitoring System (Unsterilized)

TW: "可諾" 膽固醇監測系統 (未滅菌)

Taiwan·Risk Class 1·BIOPTIK TECHNOLOGY, INC.·Registered Aug 23, 2017 – Aug 23, 2027Active

Registration details

Analysis ID: 416b2e7197e357948151b9dd01e842c0

Company information

Manufacturer: BIOPTIK TECHNOLOGY, INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: KERNEL INT'L CORP.

Product details

Intended Use: It is limited to the first level of identification of the "Manual Instruments for General Surgery (I.4800)" and "Cholesterol (Total) Test System (A.1175)" in the Classification and Grading Management Measures for Medical Devices.
Product Type (Level 1): A Clinical Chemistry and Clinical Toxicology;; I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4800 Manual instruments for general surgery; A.1175 Cholesterol (Total) Testing System
Import Information: 國產;; 委託製造;; QMS/QSD

Dates and status

Registration Date: Aug 23, 2017
Expiry Date: Aug 23, 2027

About this record

Access comprehensive regulatory information for "Kono" Cholesterol Monitoring System (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 416b2e7197e357948151b9dd01e842c0 and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is KERNEL INT'L CORP..

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