Pure Global
170256
IV
current

Catheters, Cardiac, Electrophysiologyๅฏผ็ฎก,ๅฟƒ่„,็”ต็”Ÿ็†ๅญฆ

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
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Biosense Webster, Inc.
Biosense Webster (Israel) Ltd.
United States
็พŽๅ›ฝ
33 Technology Drive, Irvine, California 92618, USA
33 Technology Drive, Irvine, California 92618, USA
Authorised Representative (AR)
Johnson & Johnson (Hong Kong) Limited
ๅผบ็”Ÿ (้ฆ™ๆธฏ) ๆœ‰้™ๅ…ฌๅธ
27386080
Regulatory Timeline
Registration Date
June 09, 2022
Expiry Date
September 22, 2027
Product Models
7 Fr. Uni-Directional and Bi-Directional Deflectable Tip CS Catheter with Compression Coil (BD710FJ282RTS, BD710DF282RTS, BD710FJ282CT, BD710DF282CT)
7 Fr. ๅธฆๅŽ‹็ผฉ็บฟๅœˆ็š„ๅ•ๅ‘ๅ’ŒๅŒๅ‘ๅ่ฝฌๅฐ–็ซฏ CS ๅฏผ็ฎก(BD710FJ282RTSใ€BD710DF282RTSใ€BD710FJ282CTใ€BD710DF282CT)