Taiwan FDA registration 3ce73be39a0227fd87608cc68df24a0f

"Sysmecon" 12 urine test strips

TW: "希森美康"12項尿液試紙

Taiwan·Risk Class 2·SYSMEX CORPORATION;; EIKEN CHEMICAL CO., LTD. NOGI PLANT.·Registered Nov 07, 2018 – Nov 07, 2028Active

Registration details

Analysis ID: 3ce73be39a0227fd87608cc68df24a0f
Customs Code: DHA05603178104

Company information

Manufacturer: SYSMEX CORPORATION;; EIKEN CHEMICAL CO., LTD. NOGI PLANT.
Manufacturer Country: Japan
Authorized Representative: SYSMEX TAIWAN CO., LTD.

Product details

Intended Use: This product is used for the semi-quantitative determination of urobilinogen, occult blood, protein, glucose, ketone bodies, bilirubin, nitrite, specific gravity, white blood cells, pH, creatinine and albumin in human urine. Suitable for visual determination or with the "Sysmecon" semi-automatic urine chemistry analyzer (UC-1000).
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1115 Urine bilirubin and its conjugates (non-quantitative) test system;; A.1785 Urethral urobilin salt (non-quantitative) test system;; A.1510 Nitrite (non-quantitative) test system
Import Information: import

Dates and status

Registration Date: Nov 07, 2018
Expiry Date: Nov 07, 2028

About this record

Access comprehensive regulatory information for "Sysmecon" 12 urine test strips in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3ce73be39a0227fd87608cc68df24a0f and manufactured by SYSMEX CORPORATION;; EIKEN CHEMICAL CO., LTD. NOGI PLANT.. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..

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