Taiwan FDA registration 18a1beedaa0c1c45351bac95b2296dcb

"Siemens" calcium-2 test reagent

TW: "西門子"鈣2檢驗試劑

Taiwan·Risk Class 2·SIEMENS HEALTHCARE DIAGNOSTICS INC.;; RANDOX LABORATORIES LTD.·Registered Apr 30, 2019 – Apr 30, 2029Active

Registration details

Analysis ID: 18a1beedaa0c1c45351bac95b2296dcb
Customs Code: DHA05603241602

Company information

Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.;; RANDOX LABORATORIES LTD.
Manufacturer Country: United Kingdom;;United States
Authorized Representative: SIEMENS HEALTHCARE LIMITED

Product details

Intended Use: This product is used in vitro diagnostics with Atellica CH Analyzer to quantitatively detect calcium in human serum, plasma (lithium heparin) and urine.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1145 Calcium Test System
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Apr 30, 2019
Expiry Date: Apr 30, 2029

About this record

Access comprehensive regulatory information for "Siemens" calcium-2 test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 18a1beedaa0c1c45351bac95b2296dcb and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.;; RANDOX LABORATORIES LTD.. 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.