100379
II
current
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This profile provides complete Hong Kong MDACS registration information for Monitoring Systems, Physiologic, Cardiac Electrophysiology. 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: Monitoring Systems, Physiologic, Cardiac Electrophysiology
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
17898
Product Code Detail
17898 Monitoring Systems, Physiologic, Cardiac Electrophysiology
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
St. Jude Medical
St. Jude Medical
United States
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One St. Jude Medical Drive, St. Paul, Minnesota 55117-9913, USA
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Authorised Representative (AR)
Abbott Medical (Hong Kong) Limited
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ฌๅธ
29967688
Regulatory Timeline
Registration Date
November 04, 2020
Expiry Date
November 05, 2025
Product Models
EnSite Velocity System (EE3000), NavX Surface Electrode Kit (EN0010), NavX Surface Electrode Kit Small (EN0010-100003333), NavX Surface Electrode Kit Large (EN0010-100003331)
EnSite ้ๅบฆ็ณป็ป (EE3000), NavX ่กจ้ข็ตๆๅฅไปถ (EN0010), ๅฐๅ NavX ่กจ้ข็ตๆๅฅไปถ (EN0010-100003333), ๅคงๅ NavX ่กจ้ข็ตๆๅฅไปถ (EN0010-100003331)