Taiwan FDA registration 0b662445bf5e65f17b83937431971873

“Balt” HYBRID Hydrophilic Guidewires

TW: “波特” 海波親水導引線
Taiwan flagTaiwan·Risk Class 2·MD·BALT EXTRUSION SAS·Registered Oct 25, 2021 – Oct 25, 2026Active
Registration details
Analysis ID
0b662445bf5e65f17b83937431971873
License Form
Ministry of Health Medical Device Import No. 035008
Customs Code
DHA05603500802
Company information
Manufacturer
BALT EXTRUSION SAS
Manufacturer Country
France
Authorized Representative
EVERMED MEDICAL ENTERPRISE CO., LTD.
Product details
Intended Use
Details are as detailed as approved Chinese instructions
Product Type (Level 1)
E Cardiovascular devices
Product Type (Level 2)
E1330 Catheter Lead
Import Information
Imported from abroad
Dates and status
Registration Date
Oct 25, 2021
Expiry Date
Oct 25, 2026
About this record

Access comprehensive regulatory information for “Balt” HYBRID Hydrophilic Guidewires in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0b662445bf5e65f17b83937431971873 and manufactured by BALT EXTRUSION SAS. The authorized representative in Taiwan is EVERMED MEDICAL ENTERPRISE CO., LTD..

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