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"Arkulai" R-glutamyltransferase test strip (unsterilized) - Taiwan Registration 412db1022bf0aef2e31d30ae16137030

Access comprehensive regulatory information for "Arkulai" R-glutamyltransferase 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 412db1022bf0aef2e31d30ae16137030 and manufactured by ARKRAY Factory, Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..

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412db1022bf0aef2e31d30ae16137030
Registration Details
Taiwan FDA Registration: 412db1022bf0aef2e31d30ae16137030
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Device Details

"Arkulai" R-glutamyltransferase test strip (unsterilized)
TW: "ๆ„›็ง‘ไพ†" r-้บฉ่ƒบ้†ฏ่ฝ‰็งป้…ถๆชขๆธฌ่ฉฆ็ด™(ๆœชๆป…่Œ)
Risk Class 1

Registration Details

412db1022bf0aef2e31d30ae16137030

DHA09402299401

Company Information

Product Details

Classification and grading management measures for medical devices "r-glutaminyl transferase (GGT) and isoenzyme test system (A.1360) first grade identification range.

A Clinical chemistry and clinical toxicology

A.1360 r-้บฉ่ƒบ้†ฏ่ฝ‰็งป้…ถ(GGT)ๅ’ŒๅŒๅŠŸ้…ถ่ฉฆ้ฉ—็ณป็ตฑ

Input;; QMS/QSD

Dates and Status

Dec 30, 2022

Dec 30, 2027