Taiwan FDA registration 0b662445bf5e65f17b83937431971873
“Balt” HYBRID Hydrophilic Guidewires
TW: “波特” 海波親水導引線
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..
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.
Free DatabasePowered by Pure Global AI89,000+ Devices