190198

Prostheses, Cardiac Valve, Biological

假体, 心脏瓣膜, 生物

Edwards Lifesciences LLC·IV·Hong Kong MDACS·Registered July 16, 2024

Device overview

Risk class: IV
Product code: 15870
State: current
Status: N/A
Product code detail: 15870 Prostheses, Cardiac Valve, Biological

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: July 16, 2024
Expiry date: July 15, 2029

Product models

Edwards SAPIEN 3-Edwards Commander Kit (S3TF120, S3TF123, S3TF126, S3TF129), Edwards SAPIEN 3-Edwards Certitude Kit (S3TA120, S3TA123, S3TA126, S3TA129), SAPIEN 3 Transcatheter Heart Valve (9600TFX), Edwards eSheath Introducer Set (9610ES14, 9610ES16), Edwards Commander Delivery System ( 9610TF20, 9610TF23, 9610TF26, 9610TF29), Edwards Transfemoral Balloon Catheter (9350BC16, 9350BC20, 9350BC23, 9350BC25 ), Crimper (9600CR), QL2530 Inflation Device (96402), QL38 Locking Syringe (96406), Edwards Certitude Introducer Sheath Set (9620IS18, 9620IS21), Edwards Certitude Delivery System (9620TA20, 9620TA23, 9620TA26, 9620TA29), Ascendra Balloon Aortic Valvuloplasty Catheter (9100BAVC)

Edwards SAPIEN 3-Edwards Commander 套件(S3TF120、S3TF123、S3TF126、S3TF129)、Edwards SAPIEN 3-Edwards Certitude 套件(S3TA120、S3TA123、S3TA126、S3TA129)、SAPIEN 3 经导管心脏瓣膜 (9600TFX)、Edwards 护套导引器套件(9610ES14、9610ES16)、Edwards Commander Delivery 系统 ( 9610TF20, 9610TF23, 9610TF26, 9610TF29), Edwards 经股球囊导管 (9350BC16, 9350BC20, 9350BC23, 9350BC25 ), 压接器 (9600CR), QL2530 充气装置 (96402), QL38 锁定注射器 (96406), Edwards Certitude 导引器鞘套件 (9620IS18、9620IS21)、Edwards Certitude 输送系统(9620TA20、9620TA23、9620TA26、9620TA29)、Ascendra 球囊主动脉瓣成形术导管 (9100BAVC)

About this record

This profile provides complete Hong Kong MDACS registration information for Prostheses, Cardiac Valve, Biological. 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

產品資訊： 假体, 心脏瓣膜, 生物