Taiwan FDA registration 8d9766f5028151d43719ba50d050a60e

"Ultron" three urinary tract infection test strips (unsterilized)

TW: "雅創" 三項泌尿道感染檢測試紙(未滅菌)

Taiwan·Risk Class 1·CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.·Registered Jan 14, 2019 – Jan 14, 2024Expired

Registration details

Analysis ID: 8d9766f5028151d43719ba50d050a60e
Customs Code: DHA09600366201

Company information

Manufacturer: CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.
Manufacturer Country: China
Authorized Representative: GORED ENTERPRISE CO., LTD.

Product details

Intended Use: It is limited to the first level of identification scope of the "Leukocyte Peroxidase Test (B.7675)", "Uric Base (Non-quantitative) Test System (A.1550)" and "Nitrite (Non-quantitative) Test System (A.1510)" of the Administrative Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1): B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1550 Uric pH (non-quantitative) testing system;; B.7675 Leukocyte peroxidase test;; A.1510 Nitrite (non-quantitative) test system
Import Information: Input;; Chinese goods

Dates and status

Registration Date: Jan 14, 2019
Expiry Date: Jan 14, 2024

About this record

Access comprehensive regulatory information for "Ultron" three urinary tract infection test strips (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 8d9766f5028151d43719ba50d050a60e and manufactured by CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.. The authorized representative in Taiwan is GORED ENTERPRISE CO., LTD..

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