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180325

Catheters, Cardiac, Electrophysiology, Mapping/Ablation

导管、心脏、电生理学、映射/消融
Biosense Webster, Inc.·IV·Hong Kong MDACS·Registered August 08, 2024
Device overview
Risk class
IV
Product code
18688
State
current
Status
N/A
Product code detail
18688 Catheters, Cardiac, Electrophysiology
Manufacturer (製造商)
Name
Biosense Webster, Inc.
Biosense Webster (Israel) Ltd.
Country
United States
美国
Address
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)
Name
Johnson & Johnson (Hong Kong) Limited
强生 (香港) 有限公司
Phone
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)
About this record

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