BeneVision Central Monitoring System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Central Monitoring System EUDAMEDBeneVision Central Monitoring System FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- Airway Adapter EUDAMED
- Model / Reference
- BeneVision EUDAMEDFDA UDI60-14100-00/GA3202/GA3212/GA3211/040-001187-00/GA3201/60-14200-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936415972417 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449040AB010000333D EUDAMED
- 510(k) Number
- K162607 FDA 510(k)
- FDA Product Code
- MSX FDA 510(k)FDA UDI
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The BeneVision Central Monitoring System is a networked physiological monitor designed for continuous, multi-parameter patient monitoring in clinical settings. It integrates real-time data acquisition, display, and analysis of vital signs such as ECG, blood pressure, pulse oximetry, and respiratory parameters, enabling comprehensive cardiovascular assessment and patient management.
This system is supplied as a reusable medical device intended for use in hospital wards, intensive care units, and operating rooms. It operates in non-sterile environments and is compatible with MRI-safe settings as per its designated specifications. The device is authorised under FDA 510K and MDR regulations, with a classification as a Class II medical device under the OpenFDA system. Multiple registration numbers and FEI numbers correspond to its various monitoring functionalities and configurations.
Frequently asked questions
Is the BeneVision Central Monitoring System designed for single-use or can it be reused in clinical settings?
The BeneVision Central Monitoring System is explicitly supplied as a reusable medical device, intended for use in hospital wards, intensive care units, and operating rooms. Since it operates in non-sterile environments, it is not intended for single-use and must be properly cleaned and maintained between patient encounters.
What types of vital signs can the BeneVision Central Monitoring System monitor, and how does it integrate these measurements?
The system is designed for continuous, multi-parameter monitoring, including ECG, blood pressure, pulse oximetry, and respiratory parameters. It integrates real-time data acquisition, display, and analysis, enabling comprehensive cardiovascular assessment and patient management across clinical settings.
Does the BeneVision Central Monitoring System have any specific compatibility requirements for MRI environments?
Yes, the BeneVision Central Monitoring System is compatible with MRI-safe settings, as noted in its specifications. This means it can be used in areas where MRI procedures are performed, provided it adheres to the designated MRI-safe guidelines.
How is the regulatory authorization for the BeneVision Central Monitoring System structured, and what does this mean for buyers?
The device holds FDA 510K clearance and MDR (Medical Device Regulation) authorization, classifying it as a Class II medical device under the OpenFDA system. This indicates it has undergone rigorous review for safety and effectiveness, ensuring compliance with both U.S. and EU regulatory standards for networked physiological monitors.
What are the key differences between the various FEI numbers and registration numbers listed for the BeneVision Central Monitoring System?
The FEI (Foreign Entity Identification) numbers and registration numbers correspond to different monitoring functionalities and configurations of the BeneVision system, such as specific parameter modules (e.g., ECG, blood pressure, respiratory monitoring) or software versions. These identifiers help track compliance and regulatory submissions for each distinct feature or variant of the device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162607 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Sources (3)
- FDA 510(k) K162607 24 fields · synced Oct 6, 2026
- FDA UDI db102315-6ea8-4901-810a-3a0ef40fcda7 32 fields · synced May 29, 2026
- EUDAMED a65a3998-ff0e-4ad3-9923-c0ea11a7b737 61 fields · synced Jul 17, 2026