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Sign in to claim this brandShenzhen 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.
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Catalogue (1080)
Page 9 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| T1 Docking Station(NO VGA) | 115-028323-00 | FDA UDI | Class II | Active |
| M-30r | M-30R | FDA UDI | Class I | Active |
| M5 Probe Extend Module(FDA, Alone) | 115-006960-00 | FDA UDI | Class II | Active |
| IBP_CO_MicrostreamCO2 module(FDA/FJ/PK.) | 115-030783-00 | FDA UDI | Class II | Active |
| NGB-001 Needle-guided Bracket/DETACH | 115-002020-00 | FDA UDI | Class II | Active |
| TM80 Main Unit(Silex/FDA) | 120-021995-00 | FDA UDI | Class II | Active |
| 3-Lead Leadset, Adt/Ped, AHA, Snap | 0010-30-42734 | FDA UDI | Class II | Active |
| DC-65S Diagnostic Ultrasound System | DC-65S | EUDAMEDFDA UDI | Class II | Active |
| Temp Cable for 400 Series Disp | 040-000091-00 | FDA UDI | Class II | Active |
| Cuff | 0683-15-0004-01 | FDA UDI | N/A | Active |
| 35C50EB Ultrasonic Transducer(FDA) | 120-000770-00 | FDA UDI | Class II | Active |
| Reusable SpO2 Sensor, Pdt, Finger-Clip | 512H-30-79061 | FDA UDI | Class II | Active |
| Charger Package(US cord) | 115-030108-00 | FDA UDI | Class II | Active |
| iDock51 Audio/Video Extend Module | 115-020783-00 | FDA UDI | Class II | Active |
| Li-ion Bat Pack (11.1V4500mAh LI23S002A) | 115-065140-00 | FDA UDI | Class II | Active |
| Bracket of SMR (Hook Bracket) | 115-033882-00 | FDA UDI | Class II | Active |
| L12-3RCs Ultrasonic Probe(FDA) | 120-018861-00 | FDA UDI | Class II | Active |
| ECG Module | 115-035885-00 | FDA UDI | Class II | Active |
| 7L4s Ultrasonic Transducer(FDA) | PL1E-30-90886 | FDA UDI | Class II | Active |
| Kit, Sidestream Co2, Adu/Ped | 6800-30-50618 | FDA UDI | Class II | Active |
| Keyboard kit for anaesthetic machine | 115-033884-00 | FDA UDI | Class II | Active |
| Serum Standard (Indirect)(FDA) | 105-011384-00 | FDA UDI | Class II | Active |
| Disposable large adult blood cuff(CM1504) | 115-054844-00 | EUDAMEDFDA UDI | Class II | Active |
| CO upgrd pkg/no accssry | 115-047285-00 | FDA UDI | Class II | Active |
| ECG Module Kit(for FDA) | 115-012414-00 | FDA UDI | Class II | Active |
| DC-86S Diagnostic Ultrasound System | DC-86S | FDA UDI | Class II | Active |
| NGB-003 Needle-guided Bracket | PR1B-30-90310 | FDA UDI | Class II | Active |
| L14-6WEUltrasonic Transducer(FDA) | 120-001761-00 | FDA UDI | Class II | Active |
| SYNC70 mainhouse(FDA) | 115-067297-00 | FDA UDI | Class II | Active |
| ZS3KP Elite Diagnostic Ultrasound System | ZS3KP Elite | FDA UDI | Class II | Active |
| Disposable Large Adult Color-coded | S1-0683-14-0004-01 | FDA UDI | Class II | Active |
| P4-2 Ultrasonic Transducer(FDA) | PP3C-30-91168 | FDA UDI | Class II | Active |
| CB10-4 Ultrasound Probe(FDA) | 120-000452-00 | FDA UDI | Class II | Active |
| L16-4HU Ultrasonic Probe(FDA) | 120-004652-00 | FDA UDI | Class II | Active |
| SMR material package(OEM) | 115-007305-00 | FDA UDI | Class II | Active |
| 3-Lead, Ecg, Univ, Snap, 36", Int'l | 0012-00-1503-15 | FDA UDI | Class II | Active |
| VS 9 Vital Signs Monitor | VS 9 | EUDAMEDFDA UDI | Class II | Active |
| GAS1 module: Auto ID Multi-Gas/O2/BIS mo | 6800-30-50841 | FDA UDI | Class II | Active |
| Cable, Xducer, Ibp, Edward, 12pin | 0010-21-12179 | FDA UDI | Class II | Active |
| NGB-004 Needle-guided Bracket | PR3A-30-91145 | FDA UDI | Class II | Active |
| Dock | 115-048379-00 | FDA UDI | Class II | Active |
| TEL-100 waterproof case(3lead IEC CLIP) | 115-010672-00 | FDA UDI | Class II | Active |
| L14-6Ns Ultrasonic Transducer(FDA) | 120-001112-01 | FDA UDI | Class II | Active |
| NGB-006 Needle-guided Bracket/STEEL/VET | 120-002152-00 | FDA UDI | Class II | Active |
| 10L24EA Ultrasound Probe (FDA) | 120-000693-00 | FDA UDI | Class II | Active |
| ABS800 Chemistry Analyzer | ABS800 | FDA UDI | Class II | Active |
| GAS3 module: Auto ID Multi-Gas/BIS modul | 6800-30-50843 | FDA UDI | Class II | Active |
| 3-Lead Leadset, Inf, AHA, Snap | 0010-30-42900 | FDA UDI | Class II | Active |
| BP10 Main Unit(FDA) | 115-047557-00 | FDA UDI | Class II | Active |
| L14-5sp Linear Array Tranducer 84008-30 | Z107-30 | FDA UDI | Class II | Active |
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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