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"Siemens" High Sensitivity Cardiac Troponin I Test Kit - Taiwan Registration 4aeb8e8ea3e0605cc9feb3ca0fb578ed

Access comprehensive regulatory information for "Siemens" High Sensitivity Cardiac Troponin I Test Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4aeb8e8ea3e0605cc9feb3ca0fb578ed and manufactured by 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.

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4aeb8e8ea3e0605cc9feb3ca0fb578ed
Registration Details
Taiwan FDA Registration: 4aeb8e8ea3e0605cc9feb3ca0fb578ed
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Device Details

"Siemens" High Sensitivity Cardiac Troponin I Test Kit
TW: "่ฅฟ้–€ๅญ" ้ซ˜้ˆๆ•ๅบฆๅฟƒ่‚Œ่‚Œ้ˆฃ่›‹็™ฝ I ๆชข้ฉ—่ฉฆๅŠ‘็›’
Risk Class 2

Registration Details

4aeb8e8ea3e0605cc9feb3ca0fb578ed

DHA05603622805

Company Information

United States

Product Details

This product is intended for in vitro diagnostic use for the quantitative determination of cardiac troponin I (cTnI) in human microvascular (finger prick) whole blood and lithium heparin, venous whole blood or plasma in combination with the Atellica VTLi Immunoassay Analyzer.

A Clinical chemistry and clinical toxicology

A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Oct 05, 2023

Oct 05, 2028