Pure Global
210232
II
current

Software, Stereotactic System, Image-Guided Cardiac Mapping/Ablation่ฝฏไปถใ€็ซ‹ไฝ“ๅฎšๅ‘็ณป็ปŸใ€ๅ›พๅƒๅผ•ๅฏผๅฟƒ่„ๆ˜ ๅฐ„/ๆถˆ่ž

This profile provides complete Hong Kong MDACS registration information for Software, Stereotactic System, Image-Guided Cardiac Mapping/Ablation. 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: Software, Stereotactic System, Image-Guided Cardiac Mapping/Ablation

็”ขๅ“่ณ‡่จŠ๏ผš ่ฝฏไปถใ€็ซ‹ไฝ“ๅฎšๅ‘็ณป็ปŸใ€ๅ›พๅƒๅผ•ๅฏผๅฟƒ่„ๆ˜ ๅฐ„/ๆถˆ่ž

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
26973
Product Code Detail
26973 Software, Stereotactic System, Image-Guided Cardiac Mapping/Ablation
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
St. Jude Medical
St. Jude Medical
United States
็พŽๅ›ฝ
One St. Jude Medical Drive, St. Paul, Minnesota, 55117-9913, USA
ๅœฃ่ฃ˜ๅพทๅŒป็–—ๅคง้“ไธ€ๅท, ๅœฃไฟ็ฝ—, ๆ˜Žๅฐผ่‹่พพๅทž, 55117-9913, ็พŽๅ›ฝ
Authorised Representative (AR)
Abbott Medical (Hong Kong) Limited
็พŽๅ›ฝ้›…ๅŸนๅŒป็–—็”จๅ“(้ฆ™ๆธฏ)ๆœ‰้™ๅ…ฌๅธ
29967688
Regulatory Timeline
Registration Date
July 22, 2021
Expiry Date
July 22, 2026
Product Models
Ensite LiveView Dynamic Display, Software License (H702601)
็Žฐๅœบๅฎžๆ—ถๅ–ๆ™ฏๅŠจๆ€ๆ˜พ็คบ,่ฝฏไปถ่ฎธๅฏ่ฏ (H702601)