180325
IV
current
Catheters, Cardiac, Electrophysiology, Mapping/Ablation导管、心脏、电生理学、映射/消融
This profile provides complete Hong Kong MDACS registration information for Catheters, Cardiac, Electrophysiology, Mapping/Ablation. 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
August 08, 2024
Expiry Date
September 18, 2028
Product Models
THERMOCOOL SMARTTOUCH Uni-Directional Navigational Catheter (D133601, D133602, D133603), THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D132701, D132702, D132703, D132704, D132705), THERMOCOOL SMARTTOUCH SF Uni-directional Navigation Catheter (D134701, D134702, D134703), THERMOCOOL SMARTTOUCH SF Bi-directional Navigation Catheter (D134801, D134802, D134803, D134804, D134805), THERMOCOOL SF Bi-directional Catheter (BDI35BDRT, BDI35DDRT, BDI35DFRT, BDI35FJRT), THERMOCOOL SF NAV Bi-directional Catheter (BNI35BDCT, BNI35BDH, BNI35BFH, BNI35DFH, BNI35FFH, BNI35FJH), THERMOCOOL SF NAV Uni-directional Catheter (D131504, D131802, D131803, D131804), THERMOCOOL SF Uni-directional Catheter (D131602, D131603, D131604)
THERMOCOOL SMARTTOUCH 单向导航导管(D133601、D133602、D133603)、THERMOCOOL SMARTTOUCH 双向导管(D132701、D132702、D132703、D132704、D132705)、THERMOCOOL SMARTTOUCH SF 单向导管(D134701、D134702、D134703)、THERMOCOOL SMARTTOUCH SF 双向导管(D134801、D134802、D134803、D134804、D134805)、THERMOCOOL SF 双向导管(BDI35BDRT、BDI35DDRT、BDI35D联邦公报T、BDI35FJRT)、THERMOCOOL SF NAV 双向导管(BNI35BDCT、BNI35BDH、BNI35BFH、BNI35DFH、BNI35FFH、BNI35FJH)、THERMOCOOL SF NAV 单向导管(D131504、D131802、D131803、D131804)、THERMOCOOL SF 单向导管(D131602、D131603、D131604)