Medical Device Division · registration 180398Active

Biosense Webster

Name: Biosense Webster — Medical Device Division 180398
Creator: Biosense Webster, Inc.
Keywords: Biosense Webster, Biosense Webster, 180398, Catheters, Vascular, Ultrasound, Image, Medical Device Division

Hong KongCatheters, Vascular, Ultrasound, ImageClass IVBiosense Webster, Inc.

Verified

Official record identity

MDACS listing number: 180398
Model name: SOUNDSTAR 3D and eco Diagnostic Ultrasound Catheters (SNDSTR10, SNDSTR10G, 10438577, 10439072, 10439011, 10439236)
Registration date: July 26, 2023
Expiry date: October 19, 2028
Source update date: September 18, 2025
Status: Active

Classification

Risk class: Class IV
Published category: Catheters, Vascular, Ultrasound, Image

Published parties

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

Official description

Catheters, Vascular, Ultrasound, Image

Additional source fields

AMD nomenclature code: 18672
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
Revision number: b

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.