Taiwan FDA registration fda2bcba1d042feb37a037daf87bef91

Sysmex specific gravity correction solution

TW: 希森美康比重校正液

Taiwan·Risk Class 2·SYSMEX CORPORATION;; EIKEN CHEMICAL CO., LTD. NOGI PLANT.·Registered Feb 03, 2017 – Feb 03, 2027Active

Registration details

Analysis ID: fda2bcba1d042feb37a037daf87bef91
Customs Code: DHA05602931407

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 a urine specific gravity refractometer for calibration of a fully automatic urine analyzer (UC-3500).
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1150 Calibrated Products
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Feb 03, 2017
Expiry Date: Feb 03, 2027

About this record

Access comprehensive regulatory information for Sysmex specific gravity correction solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fda2bcba1d042feb37a037daf87bef91 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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