Medical Device Division · registration 241108Active

Biosense Webster

Name: Biosense Webster — Medical Device Division 241108
Creator: Biosense Webster, Inc.
Keywords: Biosense Webster, Biosense Webster, 241108, Catheters, Cardiac, Electrophysiology, Medical Device Division

Hong KongCatheters, Cardiac, ElectrophysiologyClass IVBiosense Webster, Inc.

Verified

Official record identity

MDACS listing number: 241108
Model name: CELSIUS ELECTROPHYSIOLOGY CATHETER (D7BTCBL252RT, D7BTCD5L252RT, D7BTCDL252RT, D7BTCEL252RT, D7BTCFL252RT, D7TC270L252RT, D7TCPSL252RT, D6TCAL252RT, D6TCBL252RT, D6TCDL252RT, D8BTCBL252RT, D8BTCDL252RT, D8BTCFL252RT, D8BTCG5L, D7BTCJL, D7TCAL252RT, D7TCBL252RT, D7TCCL252RT, D7TCDL252RT, D7TCEL252RT, D7TCFL252RT, D6TCCL252RT, D7TAL252RT, D7TBL252RT, D7TCL252RT, D7TDL252RT, D7TEL252RT, D7TFL252RT), EZ STEER BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER (BD7TCFF4L, BD7TCDD4L, BD7TCDF4L, BD7TCFJ4L, BD7TCJJ4L), CELSIUS RMT ELECTROPHYSIOLOGY CATHETER (CR7TCS4RT), NAVISTAR ELECTROPHYSIOLOGY CATHETER (NS7TCBL174HS, NS7TCCL174HS, NS7TCDL174HS, NS7TCEL174HS, NS7TCFL174HS, NS7TCJL174HS, 118330S, 118332S), EZ STEER NAV Bl-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER (BN7TCDD4L, BN7TCDF4L, BN7TCFJ4L, BN7TCJJ4L, BN7TCFF4L), NAVISTAR RMT ELECTROPHYSIOLOGY CATHETER (NR7TCS4Y)
Registration date: October 16, 2024
Expiry date: October 15, 2029
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, CA 92618, United States Of America

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.