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Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

US

Last updated May 23, 2026

What Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. makes

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. manufactures patient monitoring devices, including the Passport Series monitors (such as the Passport 17M and Passport 12M), the VS 8, VS 8A, and VS 9 vital signs monitors, as well as the Accutorr 7 and VS-900. Their portfolio also includes the ViewMate multi-ultrasound system and the Resona 7 series diagnostic ultrasound systems (Resona 7, 7CV, 7EXP, 7S, and 7OB). The company produces central monitoring systems, such as the Hypervisor, including the TMS-6016 telemetry monitoring system.

These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s 510(k) clearance registry. The company operates with a US presence, though its headquarters are based in Shenzhen, China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

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US
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Catalogue (1076)

Page 5 of 22
DeviceModel / ReferenceRegistriesClassStatus
L13-3Ns Ultrasonic Transducer (FDA) 120-018835-00
FDA UDI
Class IIActive
C5-1U Ultrasonic Probe(FDA) 120-003599-00
FDA UDI
Class IIActive
single CO2 Module(Neonate accessory kit) 115-046939-00
FDA UDI
Class IIActive
C9-3sp Curved Array Transducer Z126-00
FDA UDI
Class IIActive
digital printer (FDA) 115-032038-00
FDA UDI
Class IIActive
Reusable SpO2 Sensor, Adt, Finger-Clip 512F-30-28263
FDA UDI
Class IIActive
NGB-043 Needle-guided Bracket 120-011952-00
FDA UDI
Class IIActive
65EC10HA Ultrasonic Transducer(FDA) PR1C-30-90905
FDA UDI
Class IIActive
Carts Lithium-ion Battery Kit 115-050178-00
FDA UDI
Class IIActive
DE10-3WU Ultrasonic Probe(FDA) 120-004626-00
FDA UDI
Class IIActive
Patient Monitor Passport 12 Passport 12
FDA UDI
Class IIActive
IBP_CO_AG Module(with 02)(FDA)II 115-050570-00
FDA UDI
Class IIActive
L14-5WU Ultrasonic Probe(FDA) 120-004216-00
FDA UDI
Class IIActive
0155 Signal Converter Pack(LED Adapter) 115-051375-00
FDA UDI
Class IIActive
Cable, Disp Temp, Probe 0011-30-90444
FDA UDI
Class IIActive
3-Lead Leadset, Neo, AHA, Clip 0010-30-42896
FDA UDI
Class IIActive
rSO2 Accessory kit (Neo) 115-054856-00
FDA UDI
Class IIActive
5-Lead, Ecg, Univ, Snap, 18", Usa 0012-00-1503-01
FDA UDI
Class IIActive
Pencil probe line package 115-042842-00
FDA UDI
Class IIActive
NGB-025 Needle-guided Bracket 120-003665-00
FDA UDI
Class IIActive
SD8-1E Ultrasonic Probe(FDA) 120-005170-00
FDA UDI
Class IIActive
Telemetry Transmitter TD-60
FDA UDI
Class IIActive
SP5-1s Transducer(FDA-SJM) 120-023004-00
FDA UDI
Class IIActive
Handle(no Encoder) 115-034030-00
FDA UDI
Class IIActive
Cuff 0683-15-0005-01
FDA UDI
Class IIActive
5-Lead, New Telemetry, AHA, Snap, 36″ EY6512B
FDA UDI
Class IIActive
Bladderless Thigh Cuff(CM1305 MW) 115-027717-00
FDA UDI
Class IIActive
Cuff 0683-15-0001-01
FDA UDI
Class IIActive
Temp probe, Adult skin 040-000057-00
FDA UDI
Class IIActive
P8-3TEE Echocardiography Transducer P8-3TEE
FDA UDI
Class IIActive
4D/TEE module kit 115-046245-00
FDA UDI
Class IIActive
SC5-1NE Ultrasonic Probe(FDA) 120-013155-00
FDA UDI
Class IIActive
3-Lead, New Telemetry, IEC, Snap, 24″ EY6307B
FDA UDI
Class IIActive
P8-3mTEE Ped Echocardiography Transducer P8-3mTEE
FDA UDI
Class IIActive
12Pin 3/5-Lead ECG Host Cable, Def-P 0010-30-42719
FDA UDI
Class IIActive
P7-3s Ultrasonic Transducer(FDA) 120-000347-00
FDA UDI
Class IIActive
M7 Expert M7 Expert
FDA UDI
Class IIActive
P10-4U Ultrasonic Probe(FDA) 120-004613-00
FDA UDI
Class IIActive
5-Lead, ECG, Univ, Pinch, 36", AAMI 0012-00-1514-03
FDA UDI
Class IIActive
M7 Ultrasound system M7
FDA UDI
Class IIActive
Anesus TEX20 Pro Diagnostic Ultrasound System Anesus TEX20 Pro
FDA UDI
Class IIActive
5-Lead Leadset, Telemetry, AHA, Clip 115-004873-00
FDA UDI
Class IIActive
NGB-012 Needle-guided Bracket/STEEL 115-001274-00
FDA UDI
Class IIActive
ECG Cable, 20'(6.2 m), ESU-P, for N/T 009-005269-00
FDA UDI
Class IIActive
L7-3s Ultrasonic Transducer(FDA) 120-022047-00
FDA UDI
Class IIActive
35C20EA Ultrasonic Transducer(Wolf) 120-004556-00
FDA UDI
Class IIActive
L14-6s Ultrasonic Transducer(FDA) 120-000225-00
FDA UDI
Class IIActive
Cable, Ecg, 3/5 Lead, Esis, 10' 0012-00-1745-03
FDA UDI
Class IIActive
Receiver Cabinet with 4 Channels 115-028187-00
FDA UDI
Class IIActive
1-Slot CO2 Module w/ kit (Neo) 115-053711-00
FDA UDI
Class IIActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Shenzhen Mindray Bio-Medical Electronics Co., LTD SHENZHEN Guangdong · CN FEI 3007603826