170255
IV
current
Catheters, Cardiac, Electrophysiologyๅฏผ็ฎก,ๅฟ่,็ต็็ๅญฆ
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
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎก,ๅฟ่,็ต็็ๅญฆ
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 (่ฃฝ้ ๅ)
Biosense Webster, Inc.
Biosense Webster (Israel) Ltd.
United States
็พๅฝ
31 Technology Drive, Suite 200, Irvine, California 92618, USA
31 Technology Drive, Suite 200, Irvine, California 92618, USA
Authorised Representative (AR)
Johnson & Johnson (Hong Kong) Limited
ๅผบ็ (้ฆๆธฏ) ๆ้ๅ
ฌๅธ
27386080
Regulatory Timeline
Registration Date
June 09, 2022
Expiry Date
September 22, 2027
Product Models
6 Fr. Deflectable tip catheter (D-1079-212-S, D-1079-213-S, D-1079-214-S, D-1079-215-S, D-1079-216-S, D-1079-217-S, D-1079-228-S, D-1079-229-S, D-1079-230-S, D-1079-231-S, D-1079-234-S, D-1079-236-S, D-1079-237-S, D-1079-238-S, D-1079-323-S), 7 Fr. Deflectable tip catheter (D-1097-550-S, D-1097-551-S, D-1097-552-S, D-1097-554-S, D-1097-568-S, D-1097-569-S, D-1097-570-S, D-1097-571-S, D-1097-602-S)
6 ๅฏๅ่ฝฌๅฐ็ซฏๅฏผ็ฎก (D-1079-212-S, D-1079-213-S, D-1079-214-S, D-1079-215-S, D-1079-216-S, D-1079-217-S, D-1079-228-S, D-1079-229-S, D-1079-230-S, D-1079-231-S, D-1079-234-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1-1079-236-S, D-1-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, 079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-1079-236-S, D-107 -1079-237-S, D-1079-238-S, D-1079-323-S), 7 Fr. ๅฏๅ่ฝฌๅฐ็ซฏๅฏผ็ฎก (D-1097-550-S, D-1097-551-S, D-1097-552-S, D-1097-554-S, D-1097-568-S, D-1097-569-S, D-1097-570-S, D-1097-571-S, D-1097-602-S)