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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 4 of 26

Device	Model / Reference	Registries	Class	Status
Creatinine Kit (Sarcosine Oxidase Method)	105-004614-00	EUDAMED	Class B	Active
MU7 Plus	MU7 Plus	EUDAMED	Class IIa	Active
Probe Cleanser	105-002225-00	EUDAMED	Class A	Active
Fluid Management System	HP200G	EUDAMED	Class IIa	Active
NIBP Cuff	CM1500C(001B-30-70679)	EUDAMEDFDA UDI	Class I	Active
Magnesium Kit (Xylidyl Blue Method)	MG1103	EUDAMED	IVD General	Active
B30 Hematology Control	105-026338-00	EUDAMED	Class B	Active
ST2 Calibrators	105-038096-00	EUDAMED	Class C	Active
Mu7p	MU7P	EUDAMED	Class IIa	Active
BC-RET Hematology Control	105-002429-00	EUDAMED	Class B	Active
Mu Ae	MU AE	EUDAMED	Class IIa	Active
SC-CAL PLUS Hematology Calibrator	105-028638-00	EUDAMED	Class B	Active
Endoscope Camera System	UX5-NOR	EUDAMED	Class I	Active
PG I/PG II/G-17 Multi Control	105-031967-00	EUDAMED	Class C	Active
Rubella Virus IgM (CLIA)	105-012512-00	EUDAMED	Class C	Active
Mu Ao	MU AO	EUDAMED	Class IIa	Active
Gas sample line	60-15300-00	EUDAMED	Class I	Active
Anesthesia Machine	A3	EUDAMEDFDA UDI	Class IIb	Active
Metabolic Multi Control	105-008554-00	EUDAMED	Class C	Active
Mobile Radiography System	MobiEye 810	EUDAMED	Class IIb	Active
Creatinine Kit (Sarcosine Oxidase Method)	105-004612-00	EUDAMED	Class B	Active
Dp-9900 Digital Ultrasonic Diagnostic Imaging System	K061189	FDA 510(k)	Class II	Active
Dc-T6 Diagnostic Ultrasound System	K120699	FDA 510(k)	Class II	Active
Dc-8/ Dc-8 Pro/ Dc-8 Cv/ Dc-8 Exp/ Dc-8s Diagnostic Ultrasound Systems	K132341	FDA 510(k)	Class II	Active
Pm-9000 Express Patient Monitor	K053234	FDA 510(k)	Class II	Active
Dp-6600 Ultrasonic Diagnostic Imaging System	K052113	FDA 510(k)	Class II	Active
Bc-3200 Auto Hematology Analyzer	K063407	FDA 510(k)	Class II	Active
Accutorr 7/VS-900/VS-900c Vital Signs Monitor	K182821	FDA 510(k)	Class II	Active
Dc-8/Dc-8 Pro/Dc-8, Cv/Dc-8, Exp/Dc-8s Diagnostic Ultrasound System	K123185	FDA 510(k)	Class II	Active
SV70 Ventilator (SV70)	K252182	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	K242231	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 Diagnostic Ultrasound System	K210699	FDA 510(k)	Class II	Active
Beneview T Series Patient Monitors, Models T8, T6 And T5	K073280	FDA 510(k)	Class II	Active
Dc-7 Diagnostic Ultrasound System, Dc-3/Dc-3t Diagnostic Ultrasound System	K102865	FDA 510(k)	Class II	Active
Pm-60 Pulse Oximeter	K072581	FDA 510(k)	Class II	Active
M7/M7t Diagnostic Ultrasound System	K103677	FDA 510(k)	Class II	Active
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	K212265	FDA 510(k)	Class II	Active
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System	K172860	FDA 510(k)	Class II	Active
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)	K190011	FDA 510(k)	Class II	Active
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System	K230768	FDA 510(k)	Class II	Active
Bs-480 Chemistry Analyzer, Bs-490 Chemistry Analyzer, Clc720i Chemistry Analyzer	K140690	FDA 510(k)	Class II	Active
Hypervisor IX Monitoring System	K150632	FDA 510(k)	Class II	Active
ZS3 and z.one pro Ultrasound Systems	K192410	FDA 510(k)	Class II	Active
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	K190206	FDA 510(k)	Class II	Active
Dc-N2/Dc-N2s Diagnostic Ultrasound System	K132779	FDA 510(k)	Class II	Active
M7/M7t Diagnostic Ultrasound System	K131690	FDA 510(k)	Class II	Active
Dc-3, Dc-3t Diagnostic Ultrasound System	K081320	FDA 510(k)	Class II	Active
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)	K152902	FDA 510(k)	Class II	Active
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors	K253170	FDA 510(k)	Class II	Active
M7/M7t Diagnostic Ultrasound System	K121010	FDA 510(k)	Class II	Active

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Shanghai International Holding Corp. GmbH(Europe) DE

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