Taiwan FDA registration 64a02075c6e636914c1edaa544ccfadc

“Abbott” Gallant Implantable Cardioverter Defibrillator

TW: “雅培” 給力植入式心律去顫器
Taiwan flagTaiwan·Risk Class 3·MD·ST. JUDE MEDICAL OPERATIONS (M) SDN. BHD.·Registered Aug 16, 2021 – Aug 16, 2026Active
Registration details
Analysis ID
64a02075c6e636914c1edaa544ccfadc
License Form
Ministry of Health Medical Device Import No. 034834
Customs Code
DHA05603483401
Company information
Manufacturer Country
Malaysia
Authorized Representative
Abbott Medical Taiwan Co.
Product details
Intended Use
Details are as detailed as approved Chinese instructions
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
Aug 16, 2021
Expiry Date
Aug 16, 2026
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About this record

Access comprehensive regulatory information for “Abbott” Gallant 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 64a02075c6e636914c1edaa544ccfadc 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, 1 companies making similar products including St. Jude Medical Operations (M) Sdn. Bhd., and 1 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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