Medical Device Division · registration 180325Active

Biosense Webster

Name: Biosense Webster — Medical Device Division 180325
Creator: Biosense Webster, Inc.
Keywords: Biosense Webster, Biosense Webster, 180325, Catheters, Cardiac, Electrophysiology, Mapping/Ablation, Medical Device Division

Hong KongCatheters, Cardiac, Electrophysiology, Mapping/AblationClass IVBiosense Webster, Inc.

Verified

Official record identity

MDACS listing number: 180325
Model name: 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)
Registration date: August 08, 2024
Expiry date: September 18, 2028
Source update date: September 18, 2025
Status: Active

Classification

Risk class: Class IV
Published category: Catheters, Cardiac, Electrophysiology, Mapping/Ablation

Published parties

Registrant / registration holder: Johnson & Johnson (Hong Kong) Limited
Manufacturer: Biosense Webster, Inc.

Official description

Catheters, Cardiac, Electrophysiology

Additional source fields

AMD nomenclature code: 18688
Traditional Chinese local responsible person: 強生 (香港) 有限公司
Local responsible person phone: 27386080
Published manufacturer address: 31 Technology Drive, Suite 200, Irvine, CA 92618, United States of America
Revision number: c

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.