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“Balt” Optima Embolization Coil System - Taiwan Registration dcda12865423c2e12699515390ec0638

Access comprehensive regulatory information for “Balt” Optima Embolization Coil System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number dcda12865423c2e12699515390ec0638 and manufactured by Balt USA, LLC. The authorized representative in Taiwan is EVERMED MEDICAL ENTERPRISE 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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Registration Details
Taiwan FDA Registration: dcda12865423c2e12699515390ec0638
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Device Details

“Balt” Optima Embolization Coil System
TW: “波特”奧丁瑪栓塞圈系統
Risk Class 3
MD

Registration Details

dcda12865423c2e12699515390ec0638

Ministry of Health Medical Device Import No. 033996

DHA05603399609

Company Information

United States

Product Details

For details, it is Chinese approved copy of the imitation order

K Devices for neuroscience

K5950 Artificial embolization device

Imported from abroad

Dates and Status

Oct 13, 2020

Oct 13, 2025