180397
IV
current
Catheters, Cardiac, Electrophysiology导管,心脏,电生理学
This profile provides complete Hong Kong MDACS registration information for Catheters, Cardiac, Electrophysiology. 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: Catheters, Cardiac, Electrophysiology
產品資訊： 导管,心脏,电生理学
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
18688
Product Code Detail
18688 Catheters, Cardiac, Electrophysiology
State
current
Status
N/A
Manufacturer (製造商)
Biosense Webster, Inc.
Biosense Webster (Israel) Ltd.
United States
美国
31 Technology Drive, Suite 200, Irvine, CA 92618, United States of America
31 Technology Drive, Suite 200, Irvine, CA 92618, 美国
Authorised Representative (AR)
Johnson & Johnson (Hong Kong) Limited
强生 (香港) 有限公司
27386080
Regulatory Timeline
Registration Date
September 22, 2023
Expiry Date
October 19, 2028
Product Models
LASSO NAV 2515 eco Circular Mapping Catheter (D-1343-01-S, D-1343-02-S), LASSO Circular Mapping Catheter (D-1220-38-S, D-1220-39-S, D-1220-40-S, D-1220-41-S, D-1220-57-S, D-1220-60-S, D-1220-61-S, D-1220-64-S, D-1220-72-S), LASSO NAV 2515 Circular Mapping Catheter (D-1290-01-S, D-1290-02-S), LASSO 2515 Circular Mapping Catheter (D-1237-01-S, D-1237-02-S), LASSO NAV Circular Mapping Catheter (D-1312-01-S, D-1312-02-S, D-1312-03-S, D-1312-04-S, D-1312-05-S, D-1312-06-S), LASSO NAV eco Circular Mapping Catheter (D-1349-01-S, D-1349-02-S, D-1349-03-S, D-1349-04-S, D-1349-05-S, D-1349-06-S), LASSO Circular Mapping Catheter with Auto ID (D-1220-79-S, D-1220-80-S, D-1220-81-S, D-1220-82-S)
套索导航 2515 eco 圆形映射导管 (D-1343-01-S, D-1343-02-S), 套索圆形映射导管 (D-1220-38-S, D-1220-39-S, D-1220-40-S, D-1220-41-S, D-1220-57-S, D-1220-60-S, D-1220-61-S, D-1220-64-S, D-1220-72-S), 套索导航 251-S, 5 圆形映射导管 (D-1290-01-S, D-1290-02-S), LASSO 2515 圆形映射导管 (D-1237-01-S, D-1237-02-S), 套索导航圆形映射导管 (D-1312-01-S, D-1312-02-S, D-1312-03-S, D-1312-04-S, D-1312-05-S, D-1312-06-S), 套索导航 生态圆形映射导管(D-1349-01-S、D-1349-02-S、D-1349-03-S、D-1349-04-S、D-1349-05-S、D-1349-06-S)、带自动 ID 的 LASSO 圆形映射导管 (D-1220-79-S、D-1220-80-S、D-1220-81-S、D-1220-82-S)