240169
IV
current
Defibrillator/Cardioverter/Pacemakers, Implantable้ค้ขคๅจ/ๅฟ่่ฝฌๅคๅจ/่ตทๆๅจ,ๆคๅ ฅๅผ
This profile provides complete Hong Kong MDACS registration information for Defibrillator/Cardioverter/Pacemakers, Implantable. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Defibrillator/Cardioverter/Pacemakers, Implantable
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
18504
Product Code Detail
18504 Defibrillator/Cardioverter/Pacemakers, Implantable
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Medtronic, Inc.
Medtronic Plc
United States
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710 Medtronic Parkway, Minneapolis, Minnesota, 55432, USA
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Authorised Representative (AR)
Regulatory Timeline
Registration Date
May 08, 2024
Expiry Date
May 07, 2029
Product Models
Aurora EV-ICD MRI SureScan (DVEA3E4), Epsila EV MRI SureScan (EV240152, EV240163), Epsila EV (EAZ101, EAZ201), Aurora EV-ICD MRI SureScan (SW041)
Aurora EV-ICD MRI SureScan (DVEA3E4), Epsila EV MRI SureScan (EV240152, EV240163), Epsila EV (EAZ101, EAZ201), Aurora EV-ICD MRI SureScan (SW041)