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 September 02, 2021

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 do Lausanne 29, 1110 Morges, Switzerland
Rue do Lausanne 29, 1110 Morges, 瑞士

Authorised representative (AR)

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

Regulatory timeline

Registration date: September 02, 2021
Expiry date: December 19, 2026

Product models

BioMatrix Alpha (BMX6-2209, BMX6-2214, BMX6-2219, BMX6-2224, BMX6-2229, BMX6-2509, BMX6-2514, BMX6-2519, BMX6-2524, BMX6-2529, BMX6-2533, BMX6-2536, BMX6-2709, BMX6-2714, BMX6-2719, BMX6-2724, BMX6-2729, BMX6-2733, BMX6-2736, BMX6-3009, BMX6-3014, BMX6-3019, BMX6-3024, BMX6-3029, BMX6-3033, BMX6-3036, BMX6-3509, BMX6-3514, BMX6-3519, BMX6-3524, BMX6-3529, BMX6-3533, BMX6-3536, BMX6-4009, BMX6-4014, BMX6-4019, BMX6-4024, BMX6-4029)

生物基质阿尔法(BMX6-2209, BMX6-2214, BMX6-2219, BMX6-2224, BMX6-2229, BMX6-2509, BMX6-2514, BMX6-2519, BMX6-2524, BMX6-2529, BMX6-2533, BMX6-2536, BMX6-2709, BMX6-2714, BMX6-2719, BMX6-2724, BMX6-2729, BMX6-2733, BMX6-2 736, BMX6-3009, BMX6-3014, BMX6-3019, BMX6-3024, BMX6-3029, BMX6-3033, BMX6-3036, BMX6-3509, BMX6-3514, BMX6-1 BMX6-3524, BMX6-3529, BMX6-3533, BMX6-3536, BMX6-4009, BMX6-4014, BMX6-4019, BMX6-4024, BMX6-4029)

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