FDA Registration
Active
🇨🇳 China
Shenzhen Mindray Bio-Medical Electronics Co.,LTD
Reg #: 3007603826
·
FEI: 3007603826
·
Expires 2026
Products
61
Proprietary Names
226
Establishment Types
3
Classifications
61
Registration Details
- Registration Name
- Shenzhen Mindray Bio-Medical Electronics Co.,LTD
- Registration Number
- 3007603826
- FEI Number
- 3007603826
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- MINDRAY BUILDING,KEJI 12TH ROAD SOUTH, HI-TECH INDUSTRIAL PARK,NANSHAN
- City
- SHENZHEN Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K212900
Owner / Operator
- Firm Name
- SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
- Operator Number
- 9058402
- Address
- MINDRAY BUILDING,KEJI 12TH RD., SOUTH, HI-TECH INDUSTRIAL PARK
- City
- NANSHAN, SHENZHEN, GUANGDONG
- State
- CN-GD
- Postal Code
- 518057
- Country
- CN
- Correspondent
- Xinbing Wang
US Agent
- Business Name
- Mindray DS USA, Inc
- Contact Name
- James Clifford
- Address
- 800 MacArthur Blvd
- City
- Mahwah
- State
- NJ
- ZIP
- 07430
- Country
- US
- [email protected]
- Phone
- 201 6709353
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2021-11-10 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2021-11-10 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2021-11-10 |
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2016-09-16 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2019-03-13 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-03-13 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2019-03-13 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2019-03-13 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2019-03-13 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2019-03-13 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2019-03-13 |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | Class 2 | Anesthesiology | No | 2019-02-20 |
| Vaporizer, Anesthesia, Non-Heated | CAD | Class 2 | Anesthesiology | No | 2018-04-26 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2023-02-02 |
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 2011-11-10 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2008-02-17 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2008-02-17 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2008-02-17 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2008-02-17 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2008-02-17 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-10-10 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2021-10-10 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2017-03-27 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2025-11-26 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2014-11-10 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2014-11-10 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2014-11-10 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2014-11-10 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2014-11-10 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2014-11-10 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2014-11-10 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2014-11-10 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2014-11-10 |
| Sv70 Ventilator | MNT | Class 2 | Anesthesiology | No | 2026-04-14 |
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2010-04-12 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2026-04-19 |
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 2011-11-10 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2016-09-12 |
| Gas-Machine, Anesthesia | BSZ | Class 2 | Anesthesiology | No | 2013-02-26 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2013-02-26 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2013-02-26 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2013-02-26 |
| Regulator, Vacuum | KDP | Class 2 | General Hospital | No | 2021-05-21 |
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2014-04-20 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2014-04-20 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2014-04-20 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2022-07-21 |
| Monitor, St Segment | MLC | Class 2 | Cardiovascular | No | 2022-07-21 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2022-07-21 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2022-07-21 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2022-07-21 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2022-07-21 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2022-07-21 |
| Tester, Electrode, Surface, Electrocardiographic | KRC | Class 2 | Cardiovascular | No | 2022-07-21 |
| Burst Suppression Detection Software For Electroencephalograph | ORT | Class 2 | Neurology | No | 2022-07-21 |
| Index-Generating Electroencephalograph Software | OLW | Class 2 | Neurology | No | 2022-07-21 |
| Calibrator For Hemoglobin And Hematocrit Measurement | KRZ | Class 2 | Hematology | No | 2016-09-16 |
| Calibrator For Red-Cell And White-Cell Counting | KSA | Class 2 | Hematology | No | 2016-09-16 |
| Calibrator For Platelet Counting | KRY | Class 2 | Hematology | No | 2016-09-16 |
| Calibrator For Cell Indices | KRX | Class 2 | Hematology | No | 2016-09-16 |
| Detergent | JCB | Class 1 | Pathology | No | 2012-01-29 |
Proprietary Names
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System
MX7P/MX7W Diagnostic Ultrasound System
MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI Diagnostic Ultrasound System
MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2,MX2 BW Diagnostic Ultrasound System
Emerus MX6,Emerus MX6 Exp, Anesus MX6,Anesus MX6 Exp, Crius MX6, Crius MX6 Exp Diagnostic Ultrasound System
MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG Diagnostic Ultrasound System
Emerus MX5,Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp Diagnostic Ultrasound System
ViewMateTM Ultrasound System
DP-6900 Digital Ultrasonic Diagnostic Imaging System
BC-5D hematology control
DP-5, DP-7 Digital Ultrasonic Diagnostic Imaging System
Diagnostic Ultrasound System(Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W)
Diagnostic Ultrasound System(Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20)
Diagnostic Ultrasound System( Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite)
Diagnostic Ultrasound System(Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp)
Diagnostic Ultrasound System(Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa,Resona IV)
Diagnostic Ultrasound System(Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T)
Diagnostic Ultrasound System(Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W)
Diagnostic Ultrasound System(Hepatus 6T,Fibrous 7,Fibrous 5,Fibrous 6,Hepatus 7S,Hepatus 5T,Hepatus 7,Hepatus 5)
Diagnostic Ultrasound System(Hepatus 6,Hepatus 7T,Hepatus 6S,Hepatus 5S)
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/ Fibrous 5 Diagnostic Ultrasound System
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S Diagnostic Ultrasound System
BeneVision Central Monitoring System
Gas Module 3
Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR Diagnostic Ultrasound System
Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite Diagnostic Ultrasound System
Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System
Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite Diagnostic Ultrasound System
Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S Diagnostic Ultrasound System
Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super Diagnostic Ultrasound System
Drager D-Vap DES
ZS3 and z.one pro Ultrasound Systems
VS Series Vital Signs Monitors (Including VS 9/VS 8/VS 8A)
Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System
V80 Anesthetic Vaporizer
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/ Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
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
M-30D DILUENT,M-53D DILUENT
Anesus I9 Easi/Eagus I9 Diagnostic Ultrasound System
Nuewa I9T/Nuewa I9 Exp/Nuewa I9 Easi/Anesus I9 Diagnostic Ultrasound System
Resona I9/Resona I9 Exp/Resona I9S/Resona I9T Diagnostic Ultrasound System
Resona I9 Easi/Resona I9 Nasa/Resona IV/Imagyn I9 Diagnostic Ultrasound System
Imagyn I9S/Imagyn I9 Easi/Nuewa I9/Nuewa I9S Diagnostic Ultrasound System
Resona I9W Diagnostic Ultrasound System
TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System, J5 Diagnostic Ultrasound System
BS-200 Chemistry Analyzer,Pointe c2000 Chemistry Analyzer
TE Air Diagnostic Ultrasound System
DC-70 Pro
DC-70T
DC-70
DC-70Exp
Vital Signs Monitors(Including VS 9, VS 8, VS 8A)
TE7 Diagnostic Ultrasound System,TE5 Diagnostic Ultrasound System,J5 Diagnostic Ultrasound System
DC-8,DC-8 PRO,DC-8 CV,DC-8 EXP,DC-8S Diagnostic Ultrasound System
Ventilator(SV600,SV800,SV700,SV900)
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System
Passport 12
Passport 8
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic
SV70 Ventilator (SV70)
BC-3200 Auto Hematology Analyzer
Diagnostic Ultrasound System(Consona N5/Consona N5 Pro/Consona N5 Super/Consona N5 Exp/Consona ER/Consona N5S)
Diagnostic Ultrasound System(Consona EI/Consona EF/Consona N5 Elite/Consona N5 Ultra/Consona N3/Consona N3 Exp)
Diagnostic Ultrasound System (MU7S); Diagnostic Ultrasound System (MU7T); Diagnostic Ultrasound System (MU7 Exp)
Diagnostic Ultrasound System (MU9P); Diagnostic Ultrasound System (MU9A); Diagnostic Ultrasound System (MU7)
Diagnostic Ultrasound System (MU7A)
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 (MU7 Pro); Diagnostic Ultrasound System (MU7 Super); Diagnostic Ultrasound System (MU7P)
Diagnostic Ultrasound System( Resona A MV, Eagus A20W, Eagus A20)
Diagnostic Ultrasound System(Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20)
Diagnostic Ultrasound System(Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite)
VS-900 Vital Signs Monitor
Rosie 4 Vital Signs Monitor
VS-900c Vital Signs Monitor
Accutorr 7 Vital Signs Monitor
Diagnostic Ultrasound System MX7P
Diagnostic Ultrasound System MX7T
Diagnostic Ultrasound System Malody
Diagnostic Ultrasound System ME8
Diagnostic Ultrasound System MX7W
Diagnostic Ultrasound System Aquila
Diagnostic Ultrasound System Vaus8
Diagnostic Ultrasound System Anesus ME7
Diagnostic Ultrasound System Vaus7
Diagnostic Ultrasound System MX8
Diagnostic Ultrasound System ME7
Diagnostic Ultrasound System Zeus
Diagnostic Ultrasound System Nuda
Diagnostic Ultrasound System MX8T
Diagnostic Ultrasound System MX7
Diagnostic Ultrasound System Anesus ME7T
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
ZS3 /z.one pro/ ViewMate Ultrasound Systems
ZS3KP Elite/ ZS3 Elite /ZS4 Ultrasound Systems
DP-6900,DP-50 Digital Ultrasonic Diagnostic Imaging System
ViewMate Multi Ultrasound System (VMM-ICE-02)
ViewMate Multi Ultrasound System (VMM-ICE-01)
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
Accutorr 7/VS-900/VS-900c Vital Signs Monitor
FUKUDA Vital Signs Monitor
Passport 17m,DPM7+
T1
Passport 12m,DPM6+
ePM Series Patient Monitors (Including ePM 10, ePM12, ePM 15, ePM 10M, ePM 12M, ePM 15M)
ePM 15A,ePM 15C,ePM 12A,ePM 12C,ePM 10A,ePM 10C,ePM 15MA,ePM 15MC,ePM 12MA,ePM 12MC,ePM 10MA,ePM 10MC
Resona 7OB/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S Diagnostic Ultrasound Syste
Resona R9/Resona R9 Exp/Resona R9 Pro/Resona R9S Diagnostic Ultrasound System
Nuewa R9/Nuewa R9 Exp/Nuewa R9 Pro/Nuewa R9S Diagnostic Ultrasound System
BS-400/CLC 720 Chemistry Analyzer
Diagnostic Ultrasound System(DC-60/DC-60S/DC-60 Exp/DC-55 )
DC-50/DC-50S/DC-51/DC-52/DC-56/DC-65/DC-65S/DC-62/DC-63/DC-65T Diagnostic Ultrasound System
M-30CFL LYSE, M-5LEO(I) LYSE, M-5LEO(II) LYSE, M-53LH LYSE
BS-800M,ABS800,BA-800M ISE KIT,BS-800M Chemistry Analyzer,BA-800M Chemistry Analyzer,ABS-800 Chemistry Analyzer
Passport Series Patient Monitors(Passport 8 and Passport 12)
Patient Monitors cPM 8 and cPM 12
DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM
Drager Vapor 2000 SERVO and Vapor 2000 ISO
Passport Series Patient Monitors (Passport 12m, Passport 17m)
A3 ANESTHESIA DELIVERY SYSTEM
A5 ANESTHESIA DELIVERY SYSTEM
Z6 Diagnostic Ultrasound System
M5 Diagnostic Ultrasound System,Various Names and Models
BeneVision N Series Patient Monitor (BeneVision N12, BeneVision N15, BeneVision N17 )
BeneVision N Series Patient Monitor (BeneVision N19, BeneVision N22,BeneVision N1)
ACCUTORR 7,VS-900 VITAL SIGNS MONITOR
Rosie 4
Panorama Patient Monitoring Network
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
Consona AE, Consona AT, Consona N6 Exp, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S Diagnostic Ultrasound System
BC-5390 Auto Hematology Analyzer
M9 Diagnostic Ultrasound System
M9T Diagnostic Ultrasound System
M9CV Diagnostic Ultrasound System
M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System
ACUSON Bonsai Diagnostic Ultrasound System
TE7/TE5/TE7 Max/ TE5 Max/TE9 Diagnostic Ultrasound System
BS-480 Chemistry Analyzer
CLC720i Chemistry Analyzer
BS-490 Chemistry Analyzer
BA-480 Chemistry Analyzer
Yumizen C560 Chemistry Analyzer
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S Diagnostic Ultrasound System
Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System
Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S Diagnostic Ultrasound System
Resona R9W, Resona R7W, Nuewa R9W, Nuewa R7W Diagnostic Ultrasound System
DC-3/DC-3T Diagnostic Ultrasound System
A8, A9 Anesthesia System
DP-10/DP-20/DP-30/DP-25 Digital Ultrasonic Diagnostic Imaging System
A7 Anesthesia System
BC-3600 Auto Hematology Analyzer
ViewMate Multi Ultrasound System (VMM-ICE-01)
ePM Series Patient Monitors (Including ePM 12A,ePM 12C,ePM 10A,ePM 10C,ePM 15MA,ePM 15MC)
ePM Series Patient Monitors (Including ePM 12MA,ePM 12MC,ePM 10MA,ePM 10MC)
ePM Series Patient Monitors (Including ePM 10, ePM12, ePM 15, ePM 10M, ePM 12M, ePM 15M ePM 15A,ePM 15C)
M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System
ZS3 Ultrasound System
ViewMate Ultrasound System
z.onepro Ultrasound System
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
V60 Anesthetic Vaporizer
Diagnostic Ultrasound System(MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/AnesusME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8)
Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp Diagnostic Ultrasound System
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi Diagnostic Ultrasound System
Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Nuewa IY Diagnostic Ultrasound System
DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
DC-90/DC-90S/DC-90Q/DC-95/DC-95S Diagnostic Ultrasound System
DC-T6 Diagnostic Ultrasound System
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB/ Resona 8 Diagnostic Ultrasound System
DC-41/DC-42/DC-40T/ DC-33/DC-36/DC-38/DC-39 Diagnostic Ultrasound System
DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM
DC-N3 PRO DIAGNOSTIC ULTRASOUND SYSTEM
A5 Anesthesia System
A4 Anesthesia System
DP-20,DP-30 Digital Ultrasonic Diagnostic Imaging System
DC-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 System
Z5 DIAGNOSTIC ULTRASOUND SYSTEM
Accutorr 3,VS-600 Vital Signs Monitor
Rosebud VC
BC-3D CONTROL (Low, Normal and High)
M7 Diagnostic Ultrasound System
DC-7 Diagonostic Ultrasound System
Diagnostic Ultrasound System(TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite)
Diagnostic Ultrasound System(Eagus TEX11/Eagus TEX11T/Eagus TEX10/Eagus TEX10T/Eagus TEX/Ares)
Diagnostic Ultrasound System(Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M)
Diagnostic Ultrasound System(TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T)
Diagnostic Ultrasound System(TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite)
DC-70/DC-70T/DC-70 PRO/DC-70 EXP DIAGNOSTIC ULTRASOUND SYSTEM
Vital Signs Monitors (specifically Accutorr 3, Rosebud)
V SERIES MONITORING SYSTEM
BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17)
BeneVision N Series Patient Monitors (Including BeneVision N19 ICU,BeneVision M22 ,BeneVision M22C)
BeneVision N Series Patient Monitors (Including BeneVision M19 , BeneVision M19C , BeneVision M17)
BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU)
BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C)
BeneVision N Series Patient Monitors (Including BeneVision N15 ICU, BeneVision N15 OR, BeneVision N15 Neo)
BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo)
BeneVision N Series Patient Monitors (Including BeneVision M12 , BeneVision M12C)
BeneVision N Series Patient Monitors (Including BeneVision N19, BeneVision N22, BeneVision N1)
BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo)
TE7 Diagnostic Ultrasound System
Z.ONE PRO
Passport Series Patient Monitors (T1)
BeneVision N Series Patient Monitor (BeneVision N19, BeneVision N22, BeneVision N1)
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
SC-CAL Plus Calibrator
BeneVision Central Monitoring System(BeneVision/ TMS-6016/Telepack-608/TMS60/TM80/TM70)
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
Mindray SV600 Ventilator, Mindray SV800 Ventilator
PROBE CLEANSER
CD 80 Detergent
M-30P PROBE CLEANSER
Wash Solution
M-30R Rinse
M-30 E-Z CLEANSER
Crius R9 CV, Anesus R9 CV, Recho R9 Super, Recho R9 Lumi, Recho R CV, Recho R CVx Diagnostic Ultrasound System
Recho R9W, Recho R9, Recho R9 Pro, Recho R9 Exp, Recho R9S, Recho R9T Diagnostic Ultrasound System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device