200426
III
current
Monitoring Systems, Physiologic็็็ๆต็ณป็ป
This profile provides complete Hong Kong MDACS registration information for Monitoring Systems, Physiologic. 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
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
12636
Product Code Detail
12636 Monitoring Systems, Physiologic
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Edwards Lifesciences LLC
Edwards Lifesciences
United States
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One Edwards Way, Irvine CA 92614, USA
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น่ทฏไธๅท, ๅฐๆนพ CA 92614, ็พๅฝ
Authorised Representative (AR)
31809428/36192691
Regulatory Timeline
Registration Date
November 04, 2022
Expiry Date
December 03, 2025
Product Models
HemoSphere Advanced Monitoring Platform (HEM1, HEMOXSC100, HEMSGM10, HEMEXPM10, HEMLTECHM10, HEMPSC100), Hemodynamic Monitoring Equipment (70CC2, 9850A, HEMDPT1000, HEMRLSTD1000, HEMBAT10, HEMOXCR1000), Co-set+ Closed Injectate System (93522)
่ก็้ซ็บง็ๆตๅนณๅฐ(HEM1,HEMOXSC100,HEMSGM10,HEMEXPM10,HEMLTECHM10,HEMPSC100),่กๆตๅจๅๅญฆ็ๆต่ฎพๅค(70CC2,9850A,HEๅป็ๅจๆขฐPT1000,HEMRLSTD1000,HEMBAT10,HEMOXCR1000),Co-set+ๅฐ้ญๅผๆณจๅฐ็ณป็ป(93522)