Taiwan FDA registration a45d7016217d8a5a1bf7a64b1af638eb

“Biotronik” Passeo-18 PTA balloon catheter

TW: “百多力”帕希爾18周邊血管氣球擴張導管
Taiwan flagTaiwan·Risk Class 2·MD·BIOTRONIK AG·Registered Feb 06, 2014 – Feb 06, 2024Expired
Registration details
Analysis ID
a45d7016217d8a5a1bf7a64b1af638eb
License Form
Ministry of Health Medical Device Import No. 025804
Customs Code
DHA05602580404
Company information
Manufacturer
BIOTRONIK AG
Manufacturer Country
Switzerland
Authorized Representative
BIOTRONIK TAIWAN LIMITED
Product details
Intended Use
For details, it is Chinese approved copy of the imitation order
Product Type (Level 1)
E Cardiovascular devices
Product Type (Level 2)
E1250 Percutaneous catheter
Import Information
Imported from abroad
Dates and status
Registration Date
Feb 06, 2014
Expiry Date
Feb 06, 2024
About this record

Access comprehensive regulatory information for “Biotronik” Passeo-18 PTA balloon catheter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a45d7016217d8a5a1bf7a64b1af638eb and manufactured by BIOTRONIK AG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.

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