Taiwan FDA registration dcda12865423c2e12699515390ec0638
“Balt” Optima Embolization Coil System
TW: “波特”奧丁瑪栓塞圈系統
Taiwan·Risk Class 3·MD·Balt USA, LLC·Registered Oct 13, 2020 – Oct 13, 2025ExpiredRegistration details
- Analysis ID
- dcda12865423c2e12699515390ec0638
- License Form
- Ministry of Health Medical Device Import No. 033996
- Customs Code
- DHA05603399609
Company information
- Manufacturer
- Balt USA, LLC
- Manufacturer Country
- United States
- Authorized Representative
- EVERMED MEDICAL ENTERPRISE CO., LTD.
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- K Devices for neuroscience
- Product Type (Level 2)
- K5950 Artificial embolization device
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 13, 2020
- Expiry Date
- Oct 13, 2025
About this record
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..
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