Pure Global
180449
II
current

Stereotactic Systems, Image-Guided, Cardiac Mapping/Ablation็ซ‹ไฝ“ๅฎšๅ‘็ณป็ปŸใ€ๅ›พๅƒๅผ•ๅฏผใ€ๅฟƒ่„ๆ˜ ๅฐ„/ๆถˆ่ž

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

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

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
18607
Product Code Detail
18607 Stereotactic Systems, 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•†)
Medtronic Inc.
Medtronic Plc
United States
็พŽๅ›ฝ
710 Medtronic Parkway, Minneapolis, MN 55432, USA
710็พŽๆ•ฆๅŠ›ๅคง่ทฏ,ๆ˜Žๅฐผ้˜ฟๆณขๅˆฉๆ–ฏ,ๆ˜Žๅฐผ่‹่พพๅทž55432,็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
January 31, 2024
Expiry Date
November 09, 2028
Product Models
CardioInsight Workstation (CIT200), CardioInsight Mapping Vest (CITVST0001S, CITVST0002M CITVST0003L CITVST0004XL)
CardioInsight ๅทฅไฝœ็ซ™ (CIT200)ใ€CardioInsight ๆ ‡ๆต‹่ƒŒๅฟƒ(CITVST0001Sใ€CITVST0002M CITVST0003L CITVST0004XL)