Medical Device Division · registration 180074Active

Merit Medical Systems

Name: Merit Medical Systems — Medical Device Division 180074
Creator: Merit Medical Systems, Inc.
Keywords: Merit Medical Systems, Merit Medical Systems, 180074, Catheters, Vascular, Angiography, Medical Device Division

Hong KongCatheters, Vascular, AngiographyClass IVMerit Medical Systems, Inc.

Verified

Official record identity

MDACS listing number: 180074
Model name: Impress Diagnostic Angiography Catheters (1624-C7, 1624-D5, 1628-005, 1628-006, 1628-007, 1628-008, 1628-009, 1628-010, 1628-013, 1628-016, 1628-017, 1628-017M, 1628-019, 1628-019M, 1628-021, 1628-037, 1628-038, 1628-043, 1628-044, 1628-050, 1628-054, 1628-059, 1628-060, 1628-061, 1628-062, 1628-063, 1628-064, 1628-065, 1628-067, 1628-068, 1628-094, 1628-108, 1628-113, 1628-118, 1628-121, 1628-133, 1628-151, 1628-152, 1628-155, 1628-181, 1628-182, 1628-183, 1628-189, 1628-192, 1628-Y8M, 410035B1, 410035B2, 410035BER, 410035HH1, 410035HH3, 410035MANI, 410035MC, 410035MOT, 410035MOTC, 410035OSB1, 410035SIM1, 410035SIM2, 410035VER, 410038B1, 410038BER, 410038CB1, 410038CB2, 410038HH1, 410038HH3, 410038HS, 410038MANI, 410038MC, 410038MPA1, 410038N1, 410038N2, 410038N3, 410038N4, 410038SIM1, 410038SIM2, 410038VER, 41103510PIG-NB, 411035STS, 411038RADIM, 411038STS, 412535HH1, 412535VER, 412538BER, 412538MPA1, 4303510PIG-NB, 43035BER, 43035KA2, 43035MODCB1, 43035RIM, 43035STR, 44035RIM, 44035STS, 44038KA2, 44038MW2, 44038STS, 4653510PIG-NB, 4653510STF-NB, 4653510UBF-NB, 465352CB1, 465352CB2, 465352HK0-8, 465352HK1-0, 465352RC, 465352SH0-8, 465352SH1-0, 465354RBI, 465356MHK-NB, 465356SHP-NB, 46535B1, 46535BER, 46535CB2, 46535MOT, 46535MOTC, 46535RC, 46535RIM, 46535SIM1, 4653810MUBF-NB, 465382CB1, 465382CB2, 46538BER, 46538CB1, 46538CB2, 46538KA2, 46538MPA1, 46538SIM1, 46538SIM2, 46538STS, 46538VER, 48035MHK1, 48035MHK2, 48035MHK3, 48035MODS, 48038MIK, 48038MODS, 48038RE, 4903510PIG-NB, 4903510STF-NB, 4903510UBF-NB, 490356MHK-NB, 490356SHP-NB, 5100354RBI, 510035B1, 510035B2, 510035BER, 510035HH1, 510035HH3, 510035MANI, 510035MC, 510035MOT, 510035OSB1, 510035RBI, 510035SIM1, 510035SIM2, 510035VER, 510038B1, 510038BER, 510038CB1, 510038CB2, 510038HH1, 510038HH3, 510038HS, 510038MANI, 510038MC, 510038MPA1, 510038N1, 510038N2, 510038N3, 510038N4, 510038SIM1, 510038SIM2, 510038VER, 51103510PIG-NB, 511035STS, 51103810PIG-NB, 511038RADIM, 511038STS, 512535HH1, 512535VER, 512538BER, 512538HH1, 512538MPA1, 5303510PIG-NB, 53035BER, 53035KA2, 53035MODCB1, 53035RIM, 53035STR, 54035RIM, 54035STS, 54038KA2, 54038STS, 5653510PIG-NB, 5653510STF-NB, 5653510UBF-NB, 565352CB1, 565352CB2, 565352HK0-8, 565352HK0-8-SOR, 565352HK1-0, 565352RC, 565352SH0-8, 565352SH1-0, 565354RBI, 565354RBI-SOR, 565356MHK-NB, 565356SHP-NB, 56535B1, 56535BER, 56535BER-SOR, 56535MOT, 56535MRIMST, 56535RBI, 56535RIM, 56535RIM-SOR, 56535SIM1, 5653810MUBF-NB, 5653810PIG-NB, 565382CB1, 565382CB2, 565386MHK-NB, 56538BER, 56538CB1, 56538CB2, 56538KA2, 56538MPA1, 56538MW2, 56538MW2-SOR, 56538SIM1, 56538SIM2, 56538STS, 56538VER, 56538VER-SOR, 57538CARN10, 57538CARN15, 57538CARN5, 57538CS, 58035MHK1, 58035MHK2, 58035MHK3, 58035RE, 58038MIK, 58038RE, 5903510PIG-NB, 5903510STF-NB, 5903510UBF-NB, 59035UAC, 5903810PIG-NB, 590386MHK-NB, 59038UAC, 5IMP100381ULT1, 5IMP10038ULT1, 7440-F5, 7440-F6, 7440-F7, 7440-G8, 7440-G9, 7440-H1, 7440-H3, 7440-H8, 7440-J4, 7440-K4, 7440-L7, 7440-M1, 7440-M3, 7440-M5), Impress Diagnostic Angiography Catheters with Legato Hydrophilic Coating (1628-095H, 410038B1-H, 410038B2-H, 410038BER-H, 410038CB2-H, 410038HH1-H, 410038MANI-H, 410038MPA1-H, 410038SIM1-H, 410038SIM2-H, 410038STS-H, 410038VER-H, 412538BER-H, 412538HH1-H, 412538STS-H, 44038KA2-H, 46538BER-H, 46538CB1-H, 46538CB2-H, 46538KA2-H, 46538STS-H, 46538VER-H, 48038MHK1-H, 48038MHK2-H, 48038MHK3-H, 510038B1-H, 510038B2-H, 510038BER-H, 510038CB2-H, 510038HH1-H, 510038MANI-H, 510038MPA1-H, 510038SIM1-H, 510038SIM2-H, 510038STS-H, 510038VER-H, 512538BER-H, 512538HH1-H, 512538STS-H, 54038KA2-H, 56538BER-H, 56538CB1-H, 56538CB2-H, 56538KA2-H, 56538RBI-H, 56538STS-H, 56538VER-H, 58038MHK1-H, 58038MHK2-H, 58038MHK3-H)
Registration date: August 29, 2023
Expiry date: April 16, 2028
Source update date: January 21, 2026
Status: Active

Classification

Risk class: Class IV
Published category: Catheters, Vascular, Angiography

Published parties

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

Official description

Catheters, Vascular, Angiography

Additional source fields

AMD nomenclature code: 10688
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.