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Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

China·CN-MF-000014156

Last updated September 17, 2026

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

The company manufactures bedside patient monitoring devices, including multi-parameter monitors like the BeneVision VMAX, reusable temperature probes, and tympanic thermometers. It also produces diagnostic reagents for in vitro tests, such as gamma-glutamyltransferase (GGT), 5-nucleotidase, inorganic phosphate (PO4³⁻), cortisol, estradiol, hemoglobin A1c eluents, and anti-thyrotropin receptor antibody calibrators. Additionally, it supplies stationary digital X-ray systems, endoscopic light sources, and airway adapters.

The portfolio includes devices regulated as Class A, B, C, I, II, IIa, IIb, III, and IVD General under global standards. These products are listed in the EU’s eudamed registry and the FDA’s 510(k) database. The company is based in Shenzhen, China.

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

Information

Country: China
Address: /, Mindray Building, Keji 12th Road South, High-Tech Industrial Park, Nanshan, Shenzhen, China
Website: http//:www.mindray.com.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 0086-755-81885636
PRRC Contact: Pei Wang
EUDAMED SRN: CN-MF-000014156
FDA FEI Number: 3009156722
DUNS Number: —

Catalogue (1266)

Page 5 of 26

Device	Model / Reference	Registries	Class	Status
Vs-800 Vital Signs Monitor	K063055	FDA 510(k)	Class II	Active
Pm-50 Pulse Oximeter And Vs-800 Vital Signs Monitor	K072235	FDA 510(k)	Class II	Active
Passport Series Patient Monitors(Passport 12m, Passport 17m)	K170876	FDA 510(k)	Class II	Active
ZS3 Ultrasound System, z.one pro Ultrasound System	K171891	FDA 510(k)	Class II	Active
BeneVision Central Monitoring System	K242728	FDA 510(k)	Class II	Active
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	K253049	FDA 510(k)	Class II	Active
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor	K221113	FDA 510(k)	Class II	Active
Dc-6 Diagnostic Ultrasound System	K063500	FDA 510(k)	Class II	Active
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	K220242	FDA 510(k)	Class II	Active
BeneVision Central Monitoring System	K220058	FDA 510(k)	Class II	Active
A8, A9 Anesthesia System	K201957	FDA 510(k)	Class II	Active
Dc-7 Diagnostic Ultrasound System	K103583	FDA 510(k)	Class II	Active
Pm-8000 Express Patient Monitor, Model Pm-8000 Express	K053193	FDA 510(k)	Class II	Active
V Series Monitoring System (including V12 and V21 Monitors)	K150352	FDA 510(k)	Class II	Active
N Series Patient Monitors	K213799	FDA 510(k)	Class II	Active
Hypervisor Vi Central Monitoring System	K062194	FDA 510(k)	Class II	Active
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System	K212900	FDA 510(k)	Class II	Active
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	K201693	FDA 510(k)	Class II	Active
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	K251601	FDA 510(k)	Class II	Active
Pm-8000 Patient Monitor, Model 8000	K032733	FDA 510(k)	Class II	Active
Modification To: Dp-9900 Digital Ultrasonic Diagnostic Imaging System, Model Dp-9900	K053346	FDA 510(k)	Class II	Active
Pulse Oximeter, Model Pm-50	K061442	EUDAMEDFDA 510(k)	Class II	Active
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System	K200001	FDA 510(k)	Class II	Active
ePM Series Patient monitors	K200015	FDA 510(k)	Class II	Active
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous	K200643	FDA 510(k)	Class II	Active
M7/M7t Diagnostic Ultrasound System	K100830	FDA 510(k)	Class II	Active
BeneVision Central Monitoring System	K183238	FDA 510(k)	Class II	Active
TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System	K203391	FDA 510(k)	Class II	Active
Dp-9900 Digital Ultrasonic Diagnostic Imaging System	K070526	FDA 510(k)	Class II	Active
Dc-3/Dc-3t Diagnostic Ultrasound System	K083505	FDA 510(k)	Class II	Active
Dc-8/Dc-8 Pro/Dc-8 Cv/Dc-8 Exp/Dc-8s Diagnostic Ultrasound System	K113647	FDA 510(k)	Class II	Active
M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound	K172970	FDA 510(k)	Class II	Active
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System	K152763	FDA 510(k)	Class II	Active
Pm-50 Pulse Oximeter	K052693	FDA 510(k)	Class II	Active
Beneview T Series Patient Monitors, Models Beneview T8, T6 And T5	K092449	FDA 510(k)	Class II	Active
Dp-9900 Digital Ultrasonic Diagnostic Imaging System	K043563	FDA 510(k)	Class II	Active
BeneVision Central Monitoring System	K162607	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Bs-400 Chemistry Analyzer, Clc 720 Chemistry Analyzer	K112377	FDA 510(k)	Class II	Active
Bc-3200 Auto Hematology Analyzer, M-30d Diluent, M-30r Rinse, M-30cfl Lyse, M-30e-Z Cleanser, M-30probe Cleanser, Bc-3d C	K093394	FDA 510(k)	Class II	Active
Dc-N3/Dc-Ns3 Diagnostic Ultrasound System	K123503	FDA 510(k)	Class II	Active
Pm Series Patient Monitors, Models Pm-9000 Express And Pm-8000 Express	K070791	FDA 510(k)	Class II	Active
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	K240684	FDA 510(k)	Class II	Active
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System	K162267	FDA 510(k)	Class II	Active
Dc-7 Diagnostic Ultrasound System	K101041	FDA 510(k)	Class II	Active
Dp-20 And Dp-30 Digital Ultrasonic Diagnostic Imaging System	K113153	FDA 510(k)	Class II	Active
Panorama Patient Monitoring Network	K150082	FDA 510(k)	Class II	Active
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	K241201	FDA 510(k)	Class II	Active
Digital Ultrasonic Diagnostic Imaging System, Model Dp-6900	K090912	FDA 510(k)	Class II	Active
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	K240115	FDA 510(k)	Class II	Active
Modification To Pm-8000 Patient Monitor	K043348	FDA 510(k)	Class II	Active

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Shanghai International Holding Corp. GmbH(Europe) DE

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