Taiwan FDA registration 4b349fd8c9e6fc96848a8bd829155f5e

“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 OPERATIONS (M) SDN. BHD.·Registered Mar 11, 2016 – Mar 11, 2026Expired
Registration details
Analysis ID
4b349fd8c9e6fc96848a8bd829155f5e
License Form
Ministry of Health Medical Device Import No. 028257
Customs Code
DHA05602825703
Company information
Manufacturer Country
Malaysia
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 11, 2016
Expiry Date
Mar 11, 2026
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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 4b349fd8c9e6fc96848a8bd829155f5e and manufactured by ST. JUDE MEDICAL OPERATIONS (M) SDN. BHD.. 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 Cardiac Rhythm Management Division;;St. Jude Medical Puerto Rico, LLC, St. Jude Medical, Cardiac Rhythm Management Division, 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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