241108
IV
current
Catheters, Cardiac, Electrophysiology导管,心脏,电生理学
This profile provides complete Hong Kong MDACS registration information for Catheters, Cardiac, Electrophysiology. 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
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
18688
Product Code Detail
18688 Catheters, Cardiac, Electrophysiology
State
current
Status
N/A
Manufacturer (製造商)
Biosense Webster, Inc.
Biosense Webster (Israel) Ltd.
United States
美国
31 Technology Drive, Suite 200, Irvine, CA 92618, United States Of America
31 Technology Drive, Suite 200, 尔湾, CA 92618, 美国
Authorised Representative (AR)
Johnson & Johnson (Hong Kong) Limited
强生 (香港) 有限公司
27386080
Regulatory Timeline
Registration Date
October 16, 2024
Expiry Date
October 15, 2029
Product Models
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)
摄氏电生理导管(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 双向电生理导管(BD7TCFF4L、BD7TCDD4L、BD7TCDF4L、BD7TCFJ4L、BD7TCJJ4L)、CELSIUS RMT 电生理导管(CR7TCS4RT)、NAVISTAR 电生理导管(NS7TCBL174HS、NS7TCCL174HS、NS7TCDL174HS、NS7TCEL174HS、NS7TCFL174HS、NS7TCJL174HS、118330S、118332S)、EZ STEER NAV Bl-DIRECTIONAL 电生理导管(BN7TCDD4L、BN7TCDF4L、BN7TCFJ4L、BN7TCJJ4L、BN7TCFF4L)、NAVISTAR RMT 电生理导管(NR7TCS4Y)