Taiwan FDA registration 2a5c942d5d9310ccf4b5dc58d652f65d

Sysmex 9 urine test strips

TW: 希森美康9項尿液試紙

Taiwan·Risk Class 2·SYSMEX CORPORATION;; EIKEN CHEMICAL CO., LTD. NOGI PLANT.·Registered Jan 26, 2017 – Jan 26, 2027Active

Registration details

Analysis ID: 2a5c942d5d9310ccf4b5dc58d652f65d
Customs Code: DHA05602930101

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 semi-quantitative determination of occult blood, glucose, protein, bilirubin, urobilinogen, pH, ketone bodies, nitrite and white blood cells in human urine. Equipped with Sysmex Automatic Urine Analyzer (UC-3500).
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.1340 Urine glucose (non-quantitative) test system;; A.1645 Urine protein or albumin (non-quantitative) testing system
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Jan 26, 2017
Expiry Date: Jan 26, 2027

About this record

Access comprehensive regulatory information for Sysmex 9 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 2a5c942d5d9310ccf4b5dc58d652f65d 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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