Taiwan FDA registration 5455dd03fb26df57ba7720d11f84349a

“SJM” Quadra Assura MP Implantable Cardioverter Defibrillator

TW: “聖猷達”克卓亞速拉多點式植入式心律去顫器
Taiwan flagTaiwan·Risk Class 3·MD·St. Jude Medical, Cardiac Rhythm Management Division·Registered Mar 08, 2019 – Mar 08, 2029Active
Registration details
Analysis ID
5455dd03fb26df57ba7720d11f84349a
License Form
Ministry of Health Medical Device Import No. 032292
Customs Code
DHA05603229207
Company information
Manufacturer Country
United States
Authorized Representative
Abbott Medical Taiwan Co.
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)
E3610 Pulse generator for implantable heart rhythm apparatus
Import Information
Imported from abroad
Dates and status
Registration Date
Mar 08, 2019
Expiry Date
Mar 08, 2029
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About this record

Access comprehensive regulatory information for “SJM” Quadra Assura MP Implantable Cardioverter Defibrillator in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 5455dd03fb26df57ba7720d11f84349a and manufactured by St. Jude Medical, Cardiac Rhythm Management Division. The authorized representative in Taiwan is Abbott Medical Taiwan Co..

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including ST. JUDE MEDICAL OPERATIONS (M) SDN. BHD., St. Jude Medical Cardiac Rhythm Management Division;;St. Jude Medical Puerto Rico, LLC, and 2 recent registrations in the same category. 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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