Medical Device Division · registration 220306Active

Biosense Webster

Name: Biosense Webster — Medical Device Division 220306
Creator: Biosense Webster, Inc.
Keywords: Biosense Webster, Biosense Webster, 220306, Catheters, Cardiac, Electrophysiology, Medical Device Division

Hong KongCatheters, Cardiac, ElectrophysiologyClass IVBiosense Webster, Inc.

Verified

Official record identity

MDACS listing number: 220306
Model name: QDOT Micro Unidirectional Catheter (D139401, D139402, D139403), QDOT Micro Bidirectional Catheter (D139501, D139502, D139503, D139504, D139505)
Registration date: October 15, 2024
Expiry date: September 29, 2027
Source update date: September 18, 2025
Status: Active

Classification

Risk class: Class IV
Published category: Catheters, Cardiac, Electrophysiology

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, California, 92618, USA

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.