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Sign in to claim this brandMindray Bio-Medical Electronics Co., Ltd.
US
Last updated May 23, 2026
What Mindray Bio-Medical Electronics Co., Ltd. makes
Mindray Bio-Medical Electronics Co., Ltd. manufactures the BC-3600 Auto Hematology Analyzer, a device designed for automated blood cell counting and analysis in clinical laboratories.
The BC-3600 Auto Hematology Analyzer is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Mindray Bio-Medical Electronics Co., Ltd. manufacture?
Mindray Bio-Medical Electronics Co., Ltd. specializes in hematology analyzers, specifically the BC-3600 Auto Hematology Analyzer. This device automates blood cell counting and analysis, which is essential for diagnosing and monitoring various blood-related conditions in clinical laboratory settings.
Where is Mindray Bio-Medical Electronics Co., Ltd. based?
Mindray Bio-Medical Electronics Co., Ltd. is headquartered in the United States. The company’s location in the US may influence its regulatory pathways, such as compliance with FDA requirements for medical devices.
How are Mindray’s devices classified under regulatory standards?
The BC-3600 Auto Hematology Analyzer, one of Mindray’s devices, is classified as a Class II medical device. This classification typically means it poses moderate risk and requires special controls to ensure its safety and effectiveness, such as performance standards or post-market surveillance.
Which regulatory registries or databases list Mindray’s devices?
The BC-3600 Auto Hematology Analyzer is listed under the FDA’s 510(k) pathway, which is a premarket submission required for most Class II devices. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and performance.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (98)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mindray | P20LXU Universal arm board pad | FDA UDI | Class I | Active |
| Mindray | P30XXU Pillow for supine position | FDA UDI | Class I | Active |
| Mindray | P04XXU Gel body roll, paediatric | FDA UDI | Class I | Active |
| Mindray | P11XXU Prone position pillow | FDA UDI | Class I | Active |
| Mindray | P28XXU Chest-hipbone pad | FDA UDI | Class I | Active |
| Mindray | A35XXU Multi-function clamp | FDA UDI | Class I | Active |
| Mindray | AA9XXU Multi-joint arm support | FDA UDI | Class I | Active |
| Mindray | A12XXU Anesthesia frame | FDA UDI | Class I | Active |
| Mindray | A19XXU Wristlet | FDA UDI | Class I | Active |
| Mindray | P26LXU Universal Head Pad | FDA UDI | Class I | Active |
| Mindray | P24SXU Universal square pad | FDA UDI | Class I | Active |
| Mindray | V04XXU Foot switch | FDA UDI | Class I | Active |
| Mindray | P06XXU Prone position pillow | FDA UDI | Class I | Active |
| Mindray | P32XXU Infant head ring | FDA UDI | Class I | Active |
| Mindray | A45XXU Mayo instrument tray | FDA UDI | Class I | Active |
| Mindray | P31XXU Infant head ring | FDA UDI | Class I | Active |
| Mindray | A29XXU Advanced leg support,a pair | FDA UDI | Class I | Active |
| Mindray | P34LXU Head ring | FDA UDI | Class I | Active |
| Mindray | A93XXU Multi-position arm board | FDA UDI | Class I | Active |
| Mindray | P07LXU Paediatric horseshoe head ring | FDA UDI | Class I | Active |
| Mindray | A16XXU Multi-joint body support | FDA UDI | Class I | Active |
| Mindray | A87XXU Lateral femur ASSY kit | FDA UDI | Class I | Active |
| Mindray | P24LXU Universal square pad | FDA UDI | Class I | Active |
| Mindray | P16SXU Horseshoe head ring | FDA UDI | Class I | Active |
| Mindray | A31XXU Side rail extension(L-shape) | FDA UDI | Class I | Active |
| Mindray | A22XXU Thigh holder,a pair | FDA UDI | Class I | Active |
| Mindray | V03CXU Upper back plate | FDA UDI | Class I | Active |
| Mindray | Orthopaedic Extension Device kit-CF | FDA UDI | Class I | Active |
| Mindray | P05XXU Lateral positioner | FDA UDI | Class I | Active |
| Mindray | P03LXU Arm/leg pad | FDA UDI | Class I | Active |
| Mindray | P15XXU Struma pad | FDA UDI | Class I | Active |
| Mindray | P21XXU Table pads,3 pieces | FDA UDI | Class I | Active |
| Mindray | P14XXU Pad for countertraction post | FDA UDI | Class I | Active |
| Mindray | P35LXU Short gel body roll | FDA UDI | Class I | Active |
| Mindray | A56XXU Upper arm extension device | FDA UDI | Class I | Active |
| Mindray | P18XXU Elbow protection strap | FDA UDI | Class I | Active |
| Mindray | P19XXU Prone pillow,full support | FDA UDI | Class I | Active |
| Mindray | A55XXU Forearm extension device | FDA UDI | Class I | Active |
| Mindray | P17SXU Long gel body roll | FDA UDI | Class I | Active |
| Mindray | P26SXU Universal Head Pad | FDA UDI | Class I | Active |
| Mindray | HyBase V6 | EUDAMEDFDA UDI | Class I | Active |
| Mindray | P27XXU Wrist protector | FDA UDI | Class I | Active |
| Mindray | A02XXU Rectal positioning device | FDA UDI | Class I | Active |
| Mindray | P29MXU Ophthalmic head pad | FDA UDI | Class I | Active |
| Mindray | P07SXU Paediatric horseshoe head ring | FDA UDI | Class I | Active |
| Mindray | P29SXU Ophthalmic pad,paediatric | FDA UDI | Class I | Active |
| Mindray | P01XXU Universal hip pad | FDA UDI | Class I | Active |
| BC-3600 Auto Hematology Analyzer | K143348 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Nanjing Mindray Bio-Medical Electronics Co., Ltd. Nanjing Jiangsu · CN FEI 3013522950