Pure Global
180398
IV
current

Catheters, Vascular, Ultrasound, Imageๅฏผ็ฎก, ่ก€็ฎก, ่ถ…ๅฃฐๆณข, ๅ›พๅƒ

This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Ultrasound, Image. 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, Vascular, Ultrasound, Image

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
18672
Product Code Detail
18672 Catheters, Vascular, Ultrasound, Image
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
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
July 26, 2023
Expiry Date
October 19, 2028
Product Models
SOUNDSTAR 3D and eco Diagnostic Ultrasound Catheters (SNDSTR10, SNDSTR10G, 10438577, 10439072, 10439011, 10439236)
SOUNDSTAR 3D ๅ’Œ eco ่ถ…ๅฃฐ่ฏŠๆ–ญๅฏผ็ฎก(SNDSTR10ใ€SNDSTR10Gใ€10438577ใ€10439072ใ€10439011ใ€10439236)