190009
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
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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
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33 Technology Drive, Irvine, California, 92618, USA
33 Technology Drive, ๅฐๆนพ, ๅ ๅฉ็ฆๅฐผไบๅท, 92618, ็พๅฝ
Authorised Representative (AR)
Johnson & Johnson (Hong Kong) Limited
ๅผบ็ (้ฆๆธฏ) ๆ้ๅ
ฌๅธ
27386080
Regulatory Timeline
Registration Date
October 05, 2023
Expiry Date
January 10, 2029
Product Models
ISMUS CATH (D7R20P14RT, 117117RT, D7R20P14CT, D6R20P12RT)
ISM CATH (D7R20P14RT, 117117RT, D7R20P14CT, D6R20P12RT)