200426

Monitoring Systems, Physiologic

生理监测系统

Edwards Lifesciences LLC·III·Hong Kong MDACS·Registered November 04, 2022

Device overview

Risk class: III
Product code: 12636
State: current
Status: N/A
Product code detail: 12636 Monitoring Systems, Physiologic

Manufacturer (製造商)

Name: Edwards Lifesciences LLC
Edwards Lifesciences
Country: United States
美国
Address: One Edwards Way, Irvine CA 92614, USA
爱德华兹路一号, 尔湾 CA 92614, 美国

Authorised representative (AR)

Name: Edwards Lifesciences Hong Kong Limited
Phone: 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)

血球高级监测平台(HEM1,HEMOXSC100,HEMSGM10,HEMEXPM10,HEMLTECHM10,HEMPSC100),血流动力学监测设备(70CC2,9850A,HE医疗器械PT1000,HEMRLSTD1000,HEMBAT10,HEMOXCR1000),Co-set+封闭式注射系统(93522)

About this record

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

產品資訊： 生理监测系统