Taiwan FDA registration f456638d1fb4f2c9a2c7df347263ceb9
Sysmecon's 11 urine test strips
TW: 希森美康11項尿液試紙
Taiwan·Risk Class 2·SYSMEX CORPORATION;; EIKEN CHEMICAL CO., LTD. NOGI PLANT.·Registered Jan 26, 2017 – Jan 26, 2027ActiveRegistration details
- Analysis ID
- f456638d1fb4f2c9a2c7df347263ceb9
- Customs Code
- DHA05602930302
Company information
- 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, white blood cells, creatinine and albumin 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 尿中膽紅素及其結合物(非定量)試驗系統;; A.1435 酮(非定量)試驗系統;; A.1225 肌氨酸酐試驗系統(Creatininetestsystem)
- Import Information
- Contract manufacturing;; input
Dates and status
- Registration Date
- Jan 26, 2017
- Expiry Date
- Jan 26, 2027
About this record
Access comprehensive regulatory information for Sysmecon's 11 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 f456638d1fb4f2c9a2c7df347263ceb9 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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