Shenzhen Mindray Bio-Medical Electronics Co.,LTD
SHENZHEN Guangdong, CN
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. appears in FDA device records in SHENZHEN Guangdong, CN. FDA records list 160 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 160FDA records hold 160 510(k) clearances for Shenzhen Mindray Bio-Medical Electronics Co.,LTD between 2004 and 2026. The busiest year on record is 2015, with 12. The most recent is 2026, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 4 |
| 2006 | 9 |
| 2007 | 7 |
| 2008 | 8 |
| 2009 | 3 |
| 2010 | 7 |
| 2011 | 5 |
| 2012 | 6 |
| 2013 | 6 |
| 2014 | 4 |
| 2015 | 12 |
| 2016 | 7 |
| 2017 | 9 |
| 2018 | 8 |
| 2019 | 11 |
| 2020 | 10 |
| 2021 | 9 |
| 2022 | 7 |
| 2023 | 4 |
| 2024 | 7 |
| 2025 | 10 |
| 2026 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | BSZ | Substantially Equivalent | |
| K260098 | ePM 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) | MHX | Substantially Equivalent | |
| K260846 | Diagnostic 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);Diagnos | IYN | Substantially Equivalent | |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | MHX | Substantially Equivalent | |
| K252182 | SV70 Ventilator (SV70) | MNT | Substantially Equivalent | |
| K253049 | Resona 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 System | IYN | Substantially Equivalent | |
| K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem | IYN | Substantially Equivalent | |
| K251853 | Consona 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 System | IYN | Substantially Equivalent | |
| K251820 | ViewMateTM Ultrasound System | IYN | Substantially Equivalent | |
| K251250 | ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02) | IYN | Substantially Equivalent | |
| K243767 | SV600, SV800 Ventilator | CBK | Substantially Equivalent | |
| K251192 | Diagnostic 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) | IYN | Substantially Equivalent | |
| K242728 | BeneVision Central Monitoring System | MSX | Substantially Equivalent | |
| K250024 | TE Air Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K250020 | Diagnostic 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); Diagnost | IYN | Substantially Equivalent | |
| K250110 | Diagnostic 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); | IYN | Substantially Equivalent | |
| K242231 | Resona 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 System | IYN | Substantially Equivalent | |
| K240375 | V80 Anesthetic Vaporizer (V80) | CAD | Substantially Equivalent | |
| K241201 | TEX20/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 System | IYN | Substantially Equivalent | |
| K241432 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K240906 | TE Air Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K240684 | Resona 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 System | IYN | Substantially Equivalent | |
| K240115 | Resona 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 System | IYN | Substantially Equivalent | |
| K231685 | TE Air Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator | CBK | Substantially Equivalent | |
| K230768 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K222928 | Resona 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 System | IYN | Substantially Equivalent | |
| K221113 | Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor | MWI | Substantially Equivalent | |
| K221496 | Consona 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 System | IYN | Substantially Equivalent | |
| K221300 | Consona 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 System | IYN | Substantially Equivalent | |
| K213799 | N Series Patient Monitors | MHX | Substantially Equivalent | |
| K220058 | BeneVision Central Monitoring System | MSX | Substantially Equivalent | |
| K220242 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K220051 | TE Air Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K212265 | TEX20/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 System | IYN | Substantially Equivalent | |
| K212900 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K211475 | Vital Signs Monitors | MWI | Substantially Equivalent | |
| K211337 | DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K210699 | Resona 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 System | IYN | Substantially Equivalent | |
| K210416 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K201957 | A8, A9 Anesthesia System | BSZ | Substantially Equivalent | |
| K203391 | TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K202405 | BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1 | MHX | Substantially Equivalent | |
| K201990 | DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K201693 | DC-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 System | IYN | Substantially Equivalent | |
| K200643 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous | IYN | Substantially Equivalent | |
| K200015 | ePM Series Patient monitors | MHX | Substantially Equivalent | |
| K200979 | DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System | IYN | Substantially Equivalent | |
| K193391 | BeneVision Central Monitoring System | MSX | Substantially Equivalent | |
| K192972 | Patient Monitor | MHX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009156722 | 3009156722 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | 1203 Nanhuan Avenue, Shenzhen Guangdong 518106 CN | 2026 | and 44 more, listed in full below |
| 3007603826 | 3007603826 | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MINDRAY BUILDING,KEJI 12TH ROAD SOUTH, SHENZHEN Guangdong 518057 CN | 2026 | and 51 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DSJAlarm, Blood-Pressure
- DRQAmplifier And Signal Conditioner, Transducer Signal
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
- KRXCalibrator For Cell Indices
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- KRYCalibrator For Platelet Counting
- KSACalibrator For Red-Cell And White-Cell Counting
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- FLLContinuous Measurement Thermometer
- MNTContinuous, Minimal Ventilatory Support, Facility Use Ventilator
- GKZCounter, Differential Cell
- DSIDetector And Alarm, Arrhythmia
- JCBDetergent
- GWMDevice, Monitoring, Intracranial Pressure
- GIFDiluent, Blood Cell
- GXYElectrode, Cutaneous
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- BSZGas-Machine, Anesthesia
- CFRHexokinase, Glucose
- OLWIndex-Generating Electroencephalograph Software
- JPKMixture, Hematology Quality Control
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- MLCMonitor, St Segment
- MLDMonitor, St Segment With Alarm
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- DQAOximeter
- DPZOximeter, Ear
- MUDOximeter, Tissue Saturation
- DSBPlethysmograph, Impedance
- GGKProducts, Red-Cell Lysing Products
- OMCReduced- Montage Standard Electroencephalograph
- KDPRegulator, Vacuum
- BZKSpirometer, Monitoring (W/Wo Alarm)
- KOIStimulator, Nerve, Peripheral, Electric
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- MSXSystem, Network And Communication, Physiological Monitors
- KRCTester, Electrode, Surface, Electrocardiographic
- DRSTransducer, Blood-Pressure, Extravascular
- ITXTransducer, Ultrasonic, Diagnostic
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- CADVaporizer, Anesthesia, Non-Heated
- CBKVentilator, Continuous, Facility Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain