Bionet BM3PLUS Patient Monitor
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Patient monitor EUDAMED
- Model / Reference
- Brio X30, Brio X50, Brio X70 EUDAMEDBrio X50 EUDAMEDBrio X70 EUDAMEDBrio X30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809276944009 EUDAMED08809276944016 EUDAMED08809276943989 EUDAMED
- Basic UDI-DI
- 880927694BNBXQU EUDAMED
- Direct Marketing DI
- 08809276944009 EUDAMED08809276944016 EUDAMED08809276943989 EUDAMED
- 510(k) Number
- K082008 FDA 510(k)
- FDA Product Code
- MWI FDA 510(k)
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
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
The Bionet BM3Plus Patient Monitor is a cardiovascular monitoring device designed to continuously track and display vital signs such as electrocardiogram (ECG), blood pressure, and other physiological parameters. Classified under product code MWI, it is intended for use in clinical settings to provide real-time patient monitoring for assessment and management of cardiac function and hemodynamic status.
This device is supplied as a reusable medical instrument, intended for use in hospital or clinical environments. It requires proper calibration, maintenance, and adherence to safety protocols as outlined in its service manual. The BM3Plus is authorized under FDA 510(k) clearance (K082008) and meets MDR compliance requirements. Storage and handling must follow manufacturer guidelines to ensure accurate performance and sterility where applicable.
Frequently asked questions
Is the Bionet BM3Plus Patient Monitor designed for single-use or can it be reused in clinical settings?
The Bionet BM3Plus Patient Monitor is explicitly supplied as a reusable medical instrument, intended for use in hospital or clinical environments. Since it is reusable, it requires proper calibration, maintenance, and adherence to safety protocols as outlined in the manufacturer’s service manual to ensure accurate performance and reliability over multiple uses.
What types of vital signs does the Bionet BM3Plus Patient Monitor track, and how is it primarily used in clinical settings?
The Bionet BM3Plus Patient Monitor continuously tracks and displays electrocardiogram (ECG), blood pressure, and other physiological parameters to assess and manage cardiac function and hemodynamic status in real time. It is designed for clinical use in settings where ongoing patient monitoring is critical, such as hospitals or intensive care units.
How should the Bionet BM3Plus Patient Monitor be stored and handled to maintain its performance?
The device must be stored and handled according to manufacturer guidelines to ensure accurate performance and reliability. While the data does not specify sterilization requirements (as it is reusable), proper maintenance, calibration, and adherence to safety protocols—outlined in the service manual—are essential to prevent degradation and ensure consistent functionality.
What regulatory pathways has the Bionet BM3Plus Patient Monitor undergone, and what does that mean for its use?
The device has undergone FDA 510(k) clearance (K082008) under the Traditional pathway, with a substantially equivalent determination by the Cardiovascular (CV) Advisory Committee. It also meets MDR compliance requirements, indicating it adheres to both U.S. and European Union regulatory standards for cardiovascular monitoring devices. This means it is authorized for use in clinical settings where real-time cardiac and hemodynamic monitoring is required.
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. Sources consulted: BIONET BM3 USER MANUAL Pdf Download | ManualsLib, Bionet BM3PlusPatientMonitor - Service Manual | PDF | Blood Pressure ..., BM3Plus Patient Monitor Manual | PDF | Blood Pressure | Input/Output
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 | K082008 | Class II | Active |
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Manufacturer
- Manufacturer
- Bionet Co., Ltd.
Sources (4)
- FDA 510(k) K082008 24 fields · synced Oct 6, 2026
- EUDAMED bfde08fe-18c7-4afb-96f6-9dd736385bd4 61 fields · synced Jun 20, 2026
- EUDAMED 17d994d7-0b69-4a64-98ab-356b2e52e615 61 fields · synced Jul 9, 2026
- EUDAMED 758369b1-2a65-4f0c-91cc-0778db8c23c4 61 fields · synced Aug 1, 2026