Pure Global
230447
IV
current

Intracardiac, ultrasound imaging, catheter, steerable, single-useๅฟƒๅ†…ใ€่ถ…ๅฃฐๆˆๅƒใ€ๅฏผ็ฎกใ€ๅฏๆ“็บตใ€ไธ€ๆฌกๆ€งไฝฟ็”จ

This profile provides complete Hong Kong MDACS registration information for Intracardiac, ultrasound imaging, catheter, steerable, single-use. 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

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
18671
Product Code Detail
18671 Catheters, Vascular, Ultrasound
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions Usa , Inc.
United States
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22010 S.E. 51st Street, Issaquah WA 98029, USA
22010 SE 51st Street, Issaquah WA 98029, ็พŽๅ›ฝ
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้—จๅญๅŒป็–—ๆœ‰้™ๅ…ฌๅธ
25833388
Regulatory Timeline
Registration Date
July 24, 2024
Expiry Date
November 27, 2028
Product Models
ACUSON AcuNav Volume ICE Ultrasound Catheter (11657912)
ACUSON AcuNav Volume ICE ่ถ…ๅฃฐๅฏผ็ฎก (11657912)