Taiwan FDA registration 7f74e390f54633c09a6c7783ac084c3c

Wuding four-in-one multi-function analyzer

TW: 五鼎四合一多功能分析儀

Taiwan·Risk Class 2·APEX BIOTECHNOLOGY CORPORATION·Registered Nov 02, 2023 – Nov 02, 2028Active

Registration details

Analysis ID: 7f74e390f54633c09a6c7783ac084c3c

Company information

Manufacturer: APEX BIOTECHNOLOGY CORPORATION
Manufacturer Country: Taiwan, Province of China
Authorized Representative: APEX BIOTECHNOLOGY CORPORATION

Product details

Intended Use: This product is used with Wuding glycosylated hemoglobin reagent cartridge to quantitatively detect the concentration of glycosylated hemoglobin in fingertip microvascular whole blood or venous whole blood, and with Wuding microalbumin reagent cartridge, creatinine reagent cartridge and microalbumin/creatinine ratio reagent cartridge, the concentration of trace albumin, creatinine and urine microalbumin/creatinine ratio ratio in urine is quantitatively detected.
Product Type (Level 1): B Hematology, Pathology and Genetics;; A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2): C.5040 白蛋白免疫試驗系統;; A.1225 肌氨酸酐試驗系統(Creatininetestsystem);; B.7470 糖(基)化血紅素分析
Import Information: QMS/QSD;; 國產

Dates and status

Registration Date: Nov 02, 2023
Expiry Date: Nov 02, 2028

About this record

Access comprehensive regulatory information for Wuding four-in-one multi-function analyzer in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7f74e390f54633c09a6c7783ac084c3c and manufactured by APEX BIOTECHNOLOGY CORPORATION. The authorized representative in Taiwan is APEX BIOTECHNOLOGY CORPORATION.

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.