210220
III
current
Heart-Lung Bypass Unitsๅฟ่บๆ่ทฏ่ฃ ็ฝฎ
This profile provides complete Hong Kong MDACS registration information for Heart-Lung Bypass Units. 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: Heart-Lung Bypass Units
็ขๅ่ณ่จ๏ผ ๅฟ่บๆ่ทฏ่ฃ ็ฝฎ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
11969
Product Code Detail
11969 Heart-Lung Bypass Units
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Spectrum Medical Ltd.
Spectrum Medical Ltd.
United Kingdom
่ฑๅฝ
Harrier 4, Meteor Business Park, Cheltenham Road East, Gluocestershire, GL2 9 QL, United Kingdom
Harrier 4, Meteor Business Park, Cheltenham Road East, Gluocestershire, GL2 9 QL, ่ฑๅฝ
Authorised Representative (AR)
IntegMed Limited
่ฑ็นๆผๆ้ๅ
ฌๅธ
35273026
Regulatory Timeline
Registration Date
June 09, 2021
Expiry Date
June 09, 2026
Product Models
Quantum Diagnostic Module (QDM), Quantum Pump Console consists of Quantum Pump Frame (QPF), Quantum Power Supply (QPS), Quantum Roller Pumps (QRP), Quantum Pump Console Module (QCM), Quantum Centrifugal Pump Drive (QCD), Quantum Smart Occluder (QSO), Quantum Ventilation Module (QVM), Quantum Workstation (QWS), Quantum Workstation 12 inch (QWS12)
้ๅญ่ฏๆญๆจกๅ(QDM),้ๅญๆณตๆงๅถๅฐ็ฑ้ๅญๆณตๆกๆถ(QPF),้ๅญ็ตๆบ(QPS),้ๅญ่พๆณต(QRP),้ๅญๆณตๆงๅถๅฐๆจกๅ(QCM),้ๅญ็ฆปๅฟๆณต้ฉฑๅจๅจ(QCD),้ๅญๆบ่ฝ้ฎ็ๅจ(QSO),้ๅญ้ๆฐๆจกๅ(QVM),้ๅญๅทฅไฝ็ซ(QWS),้ๅญๅทฅไฝ็ซ12่ฑๅฏธ(QWS12)