Pure Global
140439
IV
current

Leads, Implantable Cardiac Pacemaker, Endocardialๅฏผ่”็บฟใ€ๆคๅ…ฅๅผๅฟƒ่„่ตทๆๅ™จใ€ๅฟƒๅ†…่†œ

This profile provides complete Hong Kong MDACS registration information for Leads, Implantable Cardiac Pacemaker, Endocardial. 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: Leads, Implantable Cardiac Pacemaker, Endocardial

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
12900
Product Code Detail
12900 Leads, Implantable Cardiac Pacemaker, Endocardial
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 N.E., Minneapolis, MN 55432, USA
710็พŽๆ•ฆๅŠ›ๅคง่ทฏN.E.,ๆ˜Žๅฐผ้˜ฟๆณขๅˆฉๆ–ฏ,ๆ˜Žๅฐผ่‹่พพๅทž55432,็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
October 05, 2023
Expiry Date
February 12, 2025
Product Models
CapSureFix Novus MRI SureScan (5076) (Lead Lengths: 35 cm, 45 cm, 52 cm, 58 cm, 65 cm, 85 cm) (507635, 507645, 507652, 507658, 507665, 507685)
CapSureFix Novus MRI SureScan (5076) (ๅผ•็บฟ้•ฟๅบฆ: 35 ๅŽ˜็ฑณ, 45 ๅŽ˜็ฑณ, 52 ๅŽ˜็ฑณ, 58 ๅŽ˜็ฑณ, 65 ๅŽ˜็ฑณ, 85 ๅŽ˜็ฑณ) (507635, 507645, 507652, 507658, 507665, 507685)