Taiwan FDA registration 25b3dfb1e50742640aea812d553f316a

"Sysmecon" 10 urine test strips

TW: "希森美康"10項尿液試紙

Taiwan·Risk Class 2·SYSMEX CORPORATION;; EIKEN CHEMICAL CO., LTD. NOGI PLANT.·Registered Nov 19, 2018 – Nov 19, 2028Active

Registration details

Analysis ID: 25b3dfb1e50742640aea812d553f316a
Customs Code: DHA05603179400

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 and pH values 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.1550 Uric pH (non-quantitative) testing system;; A.1435 Ketone (non-quantitative) testing system;; A.1340 Urine glucose (non-quantitative) test system
Import Information: import

Dates and status

Registration Date: Nov 19, 2018
Expiry Date: Nov 19, 2028

About this record

Access comprehensive regulatory information for "Sysmecon" 10 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 25b3dfb1e50742640aea812d553f316a 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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