Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting

血管支架、冠状动脉支架、球囊扩张支架、药物洗脱支架

Biosensors Europe SA·IV·Hong Kong MDACS·Registered December 08, 2023

Device overview

Risk class: IV
Product code: 20383
State: current
Status: N/A
Product code detail: 20383 Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting

Manufacturer (製造商)

Name: Biosensors Europe SA
Biosense Webster (Israel) Ltd.
Country: Switzerland
瑞士
Address: Rue de Lausanne 29, 1110 Morges, Switzerland
Rue de Lausanne 29, 1110 Morges, 瑞士

Authorised representative (AR)

Name: Pacific Medical (Hong Kong) Company Limited
Phone: 23438009

Regulatory timeline

Registration date: December 08, 2023
Expiry date: February 26, 2029

Product models

BioFreedom Drug Coated Coronary Stent System (BFR1-2208, BFR1-2211, BFR1-2214, BFR1-2218, BFR1-2224, BFR1-2228, BFR1-2508, BFR1-2511, BFR1-2514, BFR1-2518, BFR1-2524, BFR1-2528, BFR1-2533, BFR1-2536, BFR1-2708, BFR1-2711, BFR1-2714, BFR1-2718, BFR1-2724, BFR1-2728, BFR1-2733, BFR1-2736, BFR1-3008, BFR1-3011, BFR1-3014, BFR1-3018, BFR1-3024, BFR1-3028, BFR1-3033, BFR1-3036, BFR1-3508, BFR1-3511, BFR1-3514, BFR1-3518, BFR1-3524, BFR1-3528, BFR1-3533, BFR1-3536, BFR1-4008, BFR1-4011, BFR1-4014, BFR1-4018, BFR1-4024, BFR1-4028, BFR1-2542, BFR1-2548, BFR1-2742, BFR1-2748, BFR1-3042, BFR1-3048, BFR1-3542, BFR1-3548)

BioFreedom药物包被冠状动脉支架系统 (B联邦公报 1-2208, B联邦公报 1-2211, B联邦公报 1-2214, B联邦公报 1-22218, B联邦公报 1-22224, B联邦公报 1-2228, B联邦公报 1-2508, B联邦公报 1-2511, B联邦公报 1-2514, B联邦公报 1-2518, B联邦公报 1-2524, B联邦公报 1-2528, B联邦公报 1-2533, B联邦公报 1-2536, B联邦公报 1-2708, B联邦公报 1-2711, B联邦公报 1-2714, B联邦公报 1-2718, B联邦公报 1-2724, B联邦公报 1-2728, B联邦公报 1-2733, B联邦公报 1-2736, B联邦公报 1-3008, B联邦公报 1-3011, B联邦公报 1-3014, B联邦公报 1-3018, B联邦公报 1-3024, B联邦公报 1-3028, B联邦公报 1-3033, B联邦公报 1-3036, B联邦公报 1-3508, B联邦公报 1-3511, B联邦公报 1-3514, B联邦公报 1-3518, B联邦公报 1-3524, B联邦公报 1-3528, B联邦公报 1-3533, B联邦公报 1-3536, B联邦公报 1-4008, B联邦公报 1-4011, B联邦公报 1-4014, B联邦公报 1-4018, B联邦公报 1-4024, B联邦公报 1-4028, B联邦公报 1-2542, B联邦公报 1-2548, B联邦公报 1-2742, B联邦公报 1-2748, B联邦公报 1-3042, B联邦公报 1-3048, B联邦公报 1-3542, B联邦公报 1-3548)

About this record

This profile provides complete Hong Kong MDACS registration information for Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting. 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: Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting

產品資訊： 血管支架、冠状动脉支架、球囊扩张支架、药物洗脱支架