Pure Global
220306
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
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DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Biosense Webster, Inc.
Biosense Webster (Israel) Ltd.
United States
็พŽๅ›ฝ
31 Technology Drive, Suite 200, Irvine, California, 92618, USA
31 Technology Drive, Suite 200, ๅฐ”ๆนพ, ๅŠ ๅˆฉ็ฆๅฐผไบšๅทž, 92618, ็พŽๅ›ฝ
Authorised Representative (AR)
Johnson & Johnson (Hong Kong) Limited
ๅผบ็”Ÿ (้ฆ™ๆธฏ) ๆœ‰้™ๅ…ฌๅธ
27386080
Regulatory Timeline
Registration Date
October 15, 2024
Expiry Date
September 29, 2027
Product Models
QDOT Micro Unidirectional Catheter (D139401, D139402, D139403), QDOT Micro Bidirectional Catheter (D139501, D139502, D139503, D139504, D139505)
QDOT ๅพฎๅž‹ๅ•ๅ‘ๅฏผ็ฎก (D139401, D139402, D139403), QDOT ๅพฎๅž‹ๅŒๅ‘ๅฏผ็ฎก (D139501, D139502, D139503, D139504, D139505)