FDA.reportPublic FDA data

Shenzhen Mindray Bio-Medical Electronics Co.,LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30076038263007603826Shenzhen Mindray Bio-Medical Electronics Co.,LTD1N2026-01-01MINDRAY BUILDING,KEJI 12TH ROAD SOUTH HI-TECH INDUSTRIAL PARK,NANSHAN SHENZHEN Guangdong CN 518057

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
971331579307740K971923DRAGER-VAPOR 2000CAD1997-09-16
971332053137486K955925CBC-CAL PLUS HEMATOLOGY CALIBRATORKRX1996-02-29
971331086158595K843962CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLEJPK1984-11-01
971331561987362K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);DiagnosIYN2026-05-11
971331586713285K260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)MHX2026-05-20
971331090274816K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)BSZ2026-06-25
971331202188887K253170uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX2026-04-16
971332012953005K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound SystemIYN2026-02-11
971331818510059K252182SV70 Ventilator (SV70)MNT2026-04-06
971331346608343K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound SystemIYN2025-11-07
971331185206277K251820ViewMateTM Ultrasound SystemIYN2025-09-12
971331051998070K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystemIYN2025-12-03
971331699826019K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02)IYN2025-09-05
971331812506504K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8)IYN2025-08-22
971331929705408K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6);IYN2025-05-16
971331248811363K250024TE Air Diagnostic Ultrasound SystemIYN2025-05-30
971331749048201K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); DiagnostIYN2025-05-19
971331210198182K243767SV600, SV800 VentilatorCBK2025-08-28
971331479877975K242728BeneVision Central Monitoring SystemMSX2025-07-31
971331012676637K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound SystemIYN2024-11-08
971331374848952K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound SystemIYN2024-09-12
971331600160214K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound SystemIYN2024-09-16
971331545651374K240906TE Air Diagnostic Ultrasound SystemIYN2024-07-23
971331960597073K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound SystemIYN2024-06-17
971331232599565K240375V80 Anesthetic Vaporizer (V80)CAD2024-10-31
971331774032624K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound SystemIYN2024-04-22
971332047368973K231685TE Air Diagnostic Ultrasound SystemIYN2023-10-26
971331244019039K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound SystemIYN2023-06-09
971331909383755K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound SystemIYN2023-02-07
971331446954314K222754ViewMate Multi Ultrasound SystemIYN2022-11-09
971331259270929K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound SystemIYN2022-09-29
971332043718839K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound SystemIYN2022-09-29
971331503476650K221267VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs MonitorMWI2022-12-15
971331268526229K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorMWI2022-12-02
971331237159677K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound SystemIYN2022-03-25
971331859545320K220107Mindray SV600 Ventilator, Mindray SV800 VentilatorCBK2023-06-16
971331863106583K220051TE Air Diagnostic Ultrasound SystemIYN2022-03-04
971331497357508K213799N Series Patient MonitorsMHX2022-07-12
971331818644445K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound SystemIYN2021-11-05
971331044523092K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound SystemIYN2021-11-16
971331304229916K211475Vital Signs MonitorsMWI2021-10-05
971331472834614K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemIYN2021-07-01
971332038232827K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound SystemIYN2021-06-10
971331206630187K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound SystemIYN2021-06-10
971331983599379K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemIYN2021-03-23
971331375232757K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound SystemIYN2021-04-08
971331114991249K202405BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1MHX2021-01-07
971331881410812K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemIYN2020-11-09
971331665026615K201957A8, A9 Anesthesia SystemBSZ2021-03-26
971331703232891K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound SystemIYN2020-08-21
971331931585585K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemIYN2020-05-28
971331718573074K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/FibrousIYN2020-07-24
971331873982951K200411Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound SystemIYN2020-04-08
971331924571320K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemIYN2020-04-02
971331809074725K200015ePM Series Patient monitorsMHX2020-06-08
971331600580376K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound SystemIYN2020-04-09
971331083614729K193391BeneVision Central Monitoring SystemMSX2020-05-21
971331346981071K192972Patient MonitorMHX2020-05-07
971331578498374K192410ZS3 and z.one pro Ultrasound SystemsIYN2019-12-19
971331604478718K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound SystemIYN2019-12-13
971331340664658K191769ePM Series Patient monitorsMHX2019-10-31
971331194813864K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound SystemIYN2019-03-08
971331789717880K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)MHX2019-07-10
971331265143613K183660DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging SystemIYN2019-04-09
971332021171959K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemIYN2019-04-04
971331319712901K183238BeneVision Central Monitoring SystemMSX2019-03-13
971331864094477K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorMWI2019-03-27
971331874575842K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemIYN2019-01-10
971331817126986K182603Z6 Diagnostic Ultrasound SystemIYN2018-11-14
971331398481678K182075BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)MHX2018-12-10
971331534411263K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemIYN2019-01-09
971331989530612K180912TE7/TE5 Diagnostic Ultrasound SystemIYN2018-07-30
971331513499363K180788Gas Module 3BZK2018-10-24
971331772004620K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticIYN2018-01-08
971331336491496K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemIYN2017-12-13
971331311704371K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundIYN2017-10-25
971331536398626K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)MHX2017-11-15
971331865616245K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemIYN2017-09-21
971331181666040K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemIYN2017-10-18
971331249138353K171311A5 Anesthesia SystemBSZ2018-01-12
971331894439252K171292A7 Anesthesia SystemBSZ2018-01-12
971331226518104K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemIYN2017-09-12
971331780323976K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound SystemIYN2017-07-10
971331998020620K170876Passport Series Patient Monitors(Passport 12m, Passport 17m)MHX2017-08-23
971331211063315K170712Accutorr 7/VS-900 Vital Signs MonitorMWI2017-08-02
971331184485567K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemIYN2017-03-23
971331734526822K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemIYN2017-04-20
971331202075707K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemIYN2016-12-15
971331578641833K162607BeneVision Central Monitoring SystemMSX2017-04-20
971331619176645K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemIYN2016-09-06
971331011421496K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemIYN2016-07-13
971331751762947K160606BC-5D Hematology ControlJPK2016-09-01
971331542104099K160429BC-5390 Auto Hematology AnalyzerGKZ2016-09-01
971331529815075K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry AnalyzerJGS2016-06-09
971331469088567K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)MHX2016-03-03
971331364602693K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)MHX2016-02-18
971331036047686K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemIYN2015-10-21
971331971538910K151175ZONARE ZS3 Diagnostic Ultrasound SystemIYN2015-05-15
971332017359729K150632Hypervisor IX Monitoring SystemMSX2015-07-06
971331499374634K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemIYN2015-03-04
971331892288415K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsIYN2015-04-10
971331875890367K150167V60 Anesthetic VaporizerCAD2015-06-30
971331729722000K150082Panorama Patient Monitoring NetworkMHX2015-09-02
971331920125964K150080DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8SIYN2015-06-12
971331276293618K143472TE7 Diagnostic Ultrasound SystemIYN2015-01-02
971331764451378K143348BC-3600 Auto Hematology AnalyzerGKZ2015-08-21
971331261506806K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)MHX2014-12-22
971331789771693K142601Panorama Patient Monitoring NetworkMHX2014-11-14
971331921346236K142552A7 Anesthesia SystemBSZ2015-01-23
971331698415338K141010M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEMIYN2014-05-14
971331985186196K140690BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZERCDQ2014-09-02
971331425853006K140030DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEMIYN2014-02-19
971331015669011K132779DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-11-19
971331294258469K132662PASSPORT SERIES PATIENT MONITORSMHX2014-08-01
971331393712469K132038ACCUTORR 7 VITAL SIGNS MONITORMWI2014-05-02
971331305569157K132037VITAL SIGNS MONITORMWI2014-05-16
971331054915878K132026V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21MHX2013-12-20
971331805789340K131690M7/M7T DIAGNOSTIC ULTRASOUND SYSTEMIYO2013-07-24
971331645673114K130833DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMIYN2013-06-21
971331672486507K130695Z5 DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-06-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN732026-05-11
MHX182026-05-20
MWI72022-12-15
BSZ62026-06-25
MSX52025-07-31
CAD42024-10-31
IYO42013-07-24
GKZ32016-09-01
CBK22025-08-28
JPK22016-09-01
CFR22012-03-23
ITX22010-11-03
MNT12026-04-06
BZK12018-10-24
JGS12016-06-09
CDQ12014-09-02
KRX11996-02-29

PMN#