220187
IV
current
Prostheses, Cardiac Valve, Biological, Tissue Leaflet, Transcatheter, Aorticๅไฝใๅฟ่็ฃ่ใ็็ฉ็ฃ่ใ็ป็ปๅฐๅถใ็ปๅฏผ็ฎกใไธปๅจ่
This profile provides complete Hong Kong MDACS registration information for Prostheses, Cardiac Valve, Biological, Tissue Leaflet, Transcatheter, Aortic. 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: Prostheses, Cardiac Valve, Biological, Tissue Leaflet, Transcatheter, Aortic
็ขๅ่ณ่จ๏ผ ๅไฝใๅฟ่็ฃ่ใ็็ฉ็ฃ่ใ็ป็ปๅฐๅถใ็ปๅฏผ็ฎกใไธปๅจ่
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
33937
Product Code Detail
33937 Prostheses, Cardiac Valve, Biological, Tissue Leaflet, Transcatheter, Aortic
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
St. Jude Medical
St. Jude Medical
United States
็พๅฝ
177 County Road B East, St. Paul, Minnesota, 55117 USA
177 County Road B East, ๅฃไฟ็ฝ, ๆๅฐผ่่พพๅท, 55117 ็พๅฝ
Authorised Representative (AR)
Abbott Medical (Hong Kong) Limited
็พๅฝ้
ๅนๅป็็จๅ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
29967688
Regulatory Timeline
Registration Date
June 29, 2022
Expiry Date
June 29, 2027
Product Models
Navitor Transcatheter Heart Valve (NVTR-23, NVTR-25, NVTR-27, NVTR-29), Navitor Loading System (NVTR-LS-SM, NVTR-LS-LG), FlexNav Delivery System (FNAV-DS-SM, FNAV-DS-LG)
Navitor ็ปๅฏผ็ฎกๅฟ่็ฃ่ (NVTR-23, NVTR-25, NVTR-27, NVTR-29), Navitor Load System (NVTR-LS-SM, NVTR-LS-LG), FlexNav Delivery System (FNAV-DS-SM, FNAV-DS-LG)