Taiwan FDA registration 1bb537fe0f5a593a377186daf36167d9

Apco blood analysis to detect cassettes

TW: 艾波可血液分析檢測卡匣
Taiwan flagTaiwan·Risk Class 2·Siemens Healthcare Diagnostics Inc.;; EPOCAL INC.·Registered Jul 06, 2021 – Jul 06, 2026Expired
Registration details
Analysis ID
1bb537fe0f5a593a377186daf36167d9
Customs Code
DHA05603467405
Company information
Manufacturer Country
Canada;;United States
Authorized Representative
SIEMENS HEALTHCARE LIMITED
Product details
Intended Use
This product is used with epoc Reader and epoc Host Mobile computer, and can be used for quantitative detection of blood gases, electrolytes and metabolites in arterial, venous or microvascular whole blood samples with or without heparin or anticoagulants. The configuration of this cartridge includes pH, pCO2, pO2, sodium, potassium, ionized calcium, chloride, total carbon dioxide glucose, lactate, blood urea nitrogen, creatinine and blood cell volume ratio sensors.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1120 血內氣體(PCO2,PO2)及血液pH值試驗系統
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Jul 06, 2021
Expiry Date
Jul 06, 2026
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About this record

Access comprehensive regulatory information for Apco blood analysis to detect cassettes in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1bb537fe0f5a593a377186daf36167d9 and manufactured by Siemens Healthcare Diagnostics Inc.;; EPOCAL INC.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including EPOCAL INC., and 1 recent registrations in the same category. 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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