Taiwan FDA registration 58fcc7dcec717e7db4d8956307f18af6

Sekisui Cystatin C Control N

TW: 積水胱蛋白C品管液

Taiwan·Risk Class 2·MD·SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT·Registered Jun 24, 2020 – Jun 24, 2025Expired

Registration details

Analysis ID: 58fcc7dcec717e7db4d8956307f18af6
License Form: Ministry of Health Medical Device Import No. 033497
Customs Code: DHA05603349704

Company information

Manufacturer: SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT
Manufacturer Country: Japan
Authorized Representative: KUO'S YUAN IN ENTERPRISE CO., LTD.

Product details

Intended Use: This product is used as a quality control for the determination of cystin C content in human serum or plasma with NORUDIA CYATATIN C on an automated analyzer.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1660 Quality Control Materials (Analytical and Non-Analytical)
Import Information: Imported from abroad

Dates and status

Registration Date: Jun 24, 2020
Expiry Date: Jun 24, 2025

About this record

Access comprehensive regulatory information for Sekisui Cystatin C Control N in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 58fcc7dcec717e7db4d8956307f18af6 and manufactured by SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT. The authorized representative in Taiwan is KUO'S YUAN IN ENTERPRISE CO., LTD..

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