Taiwan FDA registration 296cc79a18b9b3467ac5ebafa65d71d9

Apoco blood analysis system

TW: 艾波可血液分析系統
Taiwan flagTaiwan·Risk Class 2·Siemens Healthcare Diagnostics Inc.;; EPOCAL INC.·Registered Aug 28, 2024 – Aug 28, 2029Active
Registration details
Analysis ID
296cc79a18b9b3467ac5ebafa65d71d9
Customs Code
DHA05603710000
Company information
Manufacturer Country
Canada;;United States
Authorized Representative
SIEMENS HEALTHCARE LIMITED
Product details
Intended Use
This product is an in vitro diagnostic device for use with an EPOC-specific cassette and is intended for use by trained professionals in the laboratory or point-of-care as a semi-automated in vitro diagnostic device for the quantitative testing of heparinized or non-anticoagulated arterial, venous, or microvascular whole blood human samples.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1450 Lactate Test System;; A.1665 Sodium Test System;; A.1160 Bicarbonate/CO2 Test System
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Aug 28, 2024
Expiry Date
Aug 28, 2029
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About this record

Access comprehensive regulatory information for Apoco blood analysis system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 296cc79a18b9b3467ac5ebafa65d71d9 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 Siemens Healthcare Diagnostics Inc.;; 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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