Medical Device Division · registration 190163Active

Merit Medical Systems

Name: Merit Medical Systems — Medical Device Division 190163
Creator: Merit Medical Systems, Inc.
Keywords: Merit Medical Systems, Merit Medical Systems, 190163, Catheter Introducers, Vascular, Central Venous, Hemostasis Valve, Medical Device Division

Hong KongCatheter Introducers, Vascular, Central Venous, Hemostasis ValveClass IVMerit Medical Systems, Inc.

Verified

Official record identity

MDACS listing number: 190163
Model name: 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)
Registration date: April 30, 2024
Expiry date: July 11, 2029
Source update date: January 21, 2026
Status: Active

Classification

Risk class: Class IV
Published category: Catheter Introducers, Vascular, Central Venous, Hemostasis Valve

Published parties

Registrant / registration holder: Merit Medical Asia Company Limited
Manufacturer: Merit Medical Systems, Inc.

Official description

Catheter Introducers, Vascular, Central Venous, Hemostasis Valve

Additional source fields

AMD nomenclature code: 17578
Local responsible person phone: 22076851
Published manufacturer address: 1600 West Merit Parkway, South Jordan, Utah, 84095, USA
Revision number: b

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.