Pure Global
190163
IV
current

Catheter Introducers, Vascular, Central Venous, Hemostasis Valve导管介绍器、血管、中心静脉、止血阀

This profile provides complete Hong Kong MDACS registration information for Catheter Introducers, Vascular, Central Venous, Hemostasis Valve. 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: Catheter Introducers, Vascular, Central Venous, Hemostasis Valve

產品資訊: 导管介绍器、血管、中心静脉、止血阀

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
17578
Product Code Detail
17578 Catheter Introducers, Vascular, Central Venous, Hemostasis Valve
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Manufacturer (製造商)
Merit Medical Systems, Inc.
Merit Medical Systems
Jordan;United States
约旦;美国
1600 West Merit Parkway, South Jordan, Utah, 84095, USA
1600 West Merit Parkway, 南乔丹, 犹他州, 84095, 美国
Authorised Representative (AR)
Regulatory Timeline
Registration Date
April 30, 2024
Expiry Date
July 11, 2029
Product Models
Prelude SNAP Splittable Sheath Introducer with side-port (PLS-1006, PLS-1007, PLS-1008, PLS-1008.5, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-1012, PLS-1012.5, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLS-2511), Prelude SNAP Splittable Sheath Introducer without side-port (PLSX-1006, PLSX-1007, PLSX-1008, PLSX-1008.5, PLSX-1009, PLSX-1009.5, PLSX-1010, PLSX-1010.5, PLSX-1011, PLSX-1012, PLSX-1012.5, PLSX-2506, PLSX-2507, PLSX-2508, PLSX-2509, PLSX-2510, PLSX-2510.5, PLSX-2511), Hydrophilic Prelude SNAP Splittable Sheath Introducer w/side-port (PLSH-1006, PLSH-1007, PLSH-1008, PLSH-1008.5, PLSH-1009, PLSH-1009.5, PLSH-1010, PLSH-1010.5, PLSH-1011, PLSH-1012, PLSH-1012.5, PLSH-2506, PLSH-2507, PLSH-2508, PLSH-2509, PLSH-2510, PLSH-2510.5, PLSH-2511), Hydrophilic Prelude SNAP Splittable Sheath Introducer without side-port (PLSHX-1006, PLSHX-1007, PLSHX-1008, PLSHX--1008.5, PLSHX-1009, PLSHX-1009.5, PLSHX-1010, PLSHX-1010.5, PLSHX-1011, PLSHX-1012, PLSHX-1012.5, PLSHX-2506, PLSHX-2507, PLSHX-2508, PLSHX-2509, PLSHX-2510, PLSHX-2510.5, PLSHX-2511)
带侧端口的前奏 SNAP 可分体护套引入器(PLS-1006、PLS-1007、PLS-1008、PLS-1008.5、PLS-1009、PLS-1009.5、PLS-1010、PLS-1010.5、PLS-1011、PLS-1012、PLS-1012.1012. 5, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLS-2511), 前奏 SNAP 可分式护套引入器不带侧端口 (PLSX-1006, PLSX-1007, PLSX-1008, PLSX-1008.5, PLSX-1009, PLSX-1009.5, PLSX-1010, PLSX-1010.5, PLSX-1011, PLSX-1012, PLSX-1012.5, PLSX-2506, PLSX-2507, PLSX-2508, PLSX-2509, PLSX-2510, PLSX-2510.5, PLSX-2511), 亲水前奏 SNAP 可分体护套引入器,带侧端口 (PLSH-1006, PLSH-1007, PLSH-1008, PLSH-1008. 5, PLSH-1009, PLSH-1009.5, PLSH-1010, PLSH-1010.5, PLSH-1011, PLSH-1012, PLSH-1012.5, PLSH-2506, PLSH-2507, PLSH-2508, PLSH-2509, PLSH-2510, PLSH-2510.5, PLSH-2511), 亲水前奏 SNAP 可分体护套引入器,不带侧端口 (PLSHX-1006, PLSHX-1007, PLSHX-1008, PLSHX--1008, PLSHX--1008.5, PLSHX-1009, PLSHX-1009.5, PLSHX-1010, PLSHX-1010.5, PLSHX-1011, PLSHX-1012, PLSHX-1012.5, PLSHX-2506, PLSHX-2507, PLSHX-2508, PLSHX-2509, PLSHX-2510, PLSHX-2510.5, PLSHX-2511)