Taiwan FDA registration eadd206061f94dfc91fcf859152798e0

“Medtronic” Resolute Onyx Zotarolimus-Eluting Coronary Stent System

TW: “美敦力”律動歐尼克斯冠狀動脈塗藥支架系統

Taiwan·Risk Class 3·MD·MEDTRONIC IRELAND·Registered May 13, 2016 – May 13, 2026Expired

Registration details

Analysis ID: eadd206061f94dfc91fcf859152798e0
License Form: Ministry of Health Medical Device Import No. 028393
Customs Code: DHA05602839301

Company information

Manufacturer: MEDTRONIC IRELAND
Manufacturer Country: Ireland
Authorized Representative: MEDTRONIC (TAIWAN) LTD.

Product details

Intended Use: For details Chinese change in the effectiveness of the approved copy of the imitation order: for details, as in the Chinese copy of the imitation order approved copy (the original approved copy of the imitation single label on March 16, 106 was withdrawn and invalidated). Performance changes: As detailed in the Chinese copy of the imitation approved copy (the original approved copy of the imitation label approved on May 4, 109 is withdrawn and invalidated).
Product Type (Level 1): E Cardiovascular devices
Product Type (Level 2): E0001 Cardiovascular stents
Import Information: Imported from abroad

Dates and status

Registration Date: May 13, 2016
Expiry Date: May 13, 2026

About this record

Access comprehensive regulatory information for “Medtronic” Resolute Onyx Zotarolimus-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 eadd206061f94dfc91fcf859152798e0 and manufactured by MEDTRONIC IRELAND. The authorized representative in Taiwan is MEDTRONIC (TAIWAN) LTD..

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