Taiwan FDA registration 992b79d761f60013ef95194df21c58ae

"Kono" cholesterol test strip (unsterilized)

TW: "可諾" 膽固醇試紙 (未滅菌)

Taiwan·Risk Class 1·BIOPTIK TECHNOLOGY, INC.·Registered Aug 08, 2017 – Aug 08, 2027Active

Registration details

Analysis ID: 992b79d761f60013ef95194df21c58ae

Company information

Manufacturer: BIOPTIK TECHNOLOGY, INC.
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: QMS/QSD;; 國產;; 委託製造

Dates and status

Registration Date: Aug 08, 2017
Expiry Date: Aug 08, 2027

About this record

Access comprehensive regulatory information for "Kono" 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 992b79d761f60013ef95194df21c58ae and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is KERNEL INT'L CORP..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.