Taiwan FDA registration f84bdbe97ecd4bc345a06072799aabf5

“BIOTRONIK” Orsiro Sirolimus Eluting Coronary Stent System

TW: “百多力”歐禧樂西羅莫司冠狀動脈塗藥支架系統
Taiwan flagTaiwan·Risk Class 3·MD·BIOTRONIK AG·Registered Jul 31, 2013 – Jul 31, 2028Active
Registration details
Analysis ID
f84bdbe97ecd4bc345a06072799aabf5
License Form
Ministry of Health Medical Device Import No. 025217
Customs Code
DHA05602521702
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)
E0001 Cardiovascular stents
Import Information
Imported from abroad
Dates and status
Registration Date
Jul 31, 2013
Expiry Date
Jul 31, 2028
About this record

Access comprehensive regulatory information for “BIOTRONIK” Orsiro Sirolimus Eluting Coronary Stent System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number f84bdbe97ecd4bc345a06072799aabf5 and manufactured by BIOTRONIK AG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.

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