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“BIOTRONIK” Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter - Taiwan Registration 4e2afd60a03ee730dc82fa36a3315c91

Access comprehensive regulatory information for “BIOTRONIK” Passeo-18 Lux Paclitaxel releasing 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 4e2afd60a03ee730dc82fa36a3315c91 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.

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4e2afd60a03ee730dc82fa36a3315c91
Registration Details
Taiwan FDA Registration: 4e2afd60a03ee730dc82fa36a3315c91
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Device Details

“BIOTRONIK” Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter
TW: “百多力”帕西歐樂思紫杉醇釋放周邊血管氣球擴張導管
Risk Class 2
MD

Registration Details

4e2afd60a03ee730dc82fa36a3315c91

Ministry of Health Medical Device Import No. 028535

DHA05602853505

Company Information

Switzerland

Product Details

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

E Cardiovascular devices

E1250 Percutaneous catheter

Imported from abroad

Dates and Status

May 17, 2016

May 17, 2026