220250

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 August 31, 2022

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: August 31, 2022
Expiry date: August 31, 2027

Product models

BioFreedom Ultra Drug Coated Coronary Stent System (BFC1-2209, BFC1-2214, BFC1-2219, BFC1-2224, BFC1-2229, BFC1-2509, BFC1-2514, BFC1-2519, BFC1-2524, BFC1-2529, BFC1-2533, BFC1-2536, BFC1-2709, BFC1-2714, BFC1-2719, BFC1-2724, BFC1-2729, BFC1-2733, BFC1-2736, BFC1-3009, BFC1-3014, BFC1-3019, BFC1-3024, BFC1-3029, BFC1-3033, BFC1-3036, BFC1-3509, BFC1-3514, BFC1-3519, BFC1-3524, BFC1-3529, BFC1-3533, BFC1-3536, BFC1-4009, BFC1-4014, BFC1-4019, BFC1-4024, BFC1-4029)

BioFreedom 超药物包被冠状动脉支架系统 (BFC1-2209, BFC1-2214, BFC1-2219, BFC1-2224, BFC1-2229, BFC1-2509, BFC1-2514, BFC1-2519, BFC1-2524, BFC1-2529, BFC1-2533, BFC1-2536, BFC1-2709, BFC1-2714, BFC1-2719, BFC1-2724, BFC1-2729, BFC1-2733, BFC1-2709, BFC1-2714, BFC1-2719, BFC1-2719, BFC1-2719, BFC1-2719 724, BFC1-2729, BFC1-2733, BFC1-2733, BFC1-2733 -2736, BFC1-3009, BFC1-3014, BFC1-3019, BFC1-3024, BFC1-3029, BFC1-3033, BFC1-3036, BFC1-3509, BFC1-3514, BFC1-3519, BFC1-3524, BFC1-3529, BFC1-3533, BFC1-3536, BFC1-4009, BFC1-4014, BFC1-4019, BFC1-4024, BFC1-4029)

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