Taiwan FDA registration a4feff9ed70491e0a6514e48df738082

"Siemens" cystatin reagent group

TW: “西門子” 胱抑素試劑組

Taiwan·Risk Class 2·RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.·Registered Feb 27, 2019 – Feb 27, 2029Active

Registration details

Analysis ID: a4feff9ed70491e0a6514e48df738082
Customs Code: DHA05603219305

Company information

Manufacturer: RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.
Manufacturer Country: United Kingdom;;United States
Authorized Representative: SIEMENS HEALTHCARE LIMITED

Product details

Intended Use: This product is used for in vitro diagnosis and needs to be used with Atellica CH Analyzer to quantitatively detect cystatin C in human serum and plasma (heparin lithium, EDTA potassium salt).
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1150 校正品;; A.1225 肌氨酸酐試驗系統(Creatininetestsystem)
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Feb 27, 2019
Expiry Date: Feb 27, 2029

About this record

Access comprehensive regulatory information for "Siemens" cystatin reagent group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a4feff9ed70491e0a6514e48df738082 and manufactured by RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.