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SpotChem EZ "Arkray" (SP-4430)(Non-Sterile) - Taiwan Registration 2f7fb59f2a5432971ed8d5d5a82f73aa

Access comprehensive regulatory information for SpotChem EZ "Arkray" (SP-4430)(Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2f7fb59f2a5432971ed8d5d5a82f73aa and manufactured by Arkray Factory Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..

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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2f7fb59f2a5432971ed8d5d5a82f73aa
Registration Details
Taiwan FDA Registration: 2f7fb59f2a5432971ed8d5d5a82f73aa
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Device Details

SpotChem EZ "Arkray" (SP-4430)(Non-Sterile)
TW: "ๆ„›็ง‘ไพ†" ็”ŸๅŒ–ๅˆ†ๆžๅ„€(ๆœชๆป…่Œ)
Risk Class 1
MD

Registration Details

2f7fb59f2a5432971ed8d5d5a82f73aa

Ministry of Health Medical Device Import Registration No. 000472

DHA08400047205

Company Information

Product Details

Fully automatic dry biochemical analyzer for detecting the concentration of biochemical reactions in human serum, plasma, whole blood (only for Hb).

A Clinical chemistry and clinical toxicology

A2160 Individual photometric chemistry analyzer for clinical use

Imported from abroad

Dates and Status

Oct 01, 2021

Oct 31, 2025