BE Micro TREA
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- BE Micro EUDAMEDFDA UDI
- Generic Name
- Electroencephalographic ambulatory recorder FDA UDI
- Device Name
- EEG Family EUDAMEDEEG Long Term-Abulatory System FDA UDI
- Model / Reference
- B9800073000 EUDAMEDFDA UDI
- Description
- EEG Long Term-Abulatory System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056446900000 EUDAMEDFDA UDI
- Basic UDI-DI
- 080564469EEG_BE EUDAMED
- 510(k) Number
- K093728 FDA 510(k)
- FDA Product Code
- OLV FDA 510(k)FDA UDIDQA FDA UDIGWQ FDA UDIGWL FDA UDIMNR FDA UDI
- EMDN Code
- Z12109099 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Electroencephalographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 882.1400 FDA 510(k)
- Regulation Number
- 882.1400 FDA 510(k)FDA UDI870.2700 FDA UDI882.1835 FDA UDI868.2375 FDA UDI
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Neurology 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
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The BE Micro TREA is a Standard Polysomnograph with Electroencephalograph (EEG), designed for recording and monitoring physiological signals in neurology. It captures EEG data, enabling continuous assessment of brain activity for diagnostic purposes, including sleep studies and polysomnography.
Supplied as a reusable device, the BE Micro TREA operates in both hospital and home environments under physician supervision. It features a backlit LCD display for real-time monitoring of recording progress, impedance, and waveforms. Authorized under FDA 510(k) clearance and MDR, it adheres to regulatory standards for Class II medical devices (regulation number 882.1400).
Frequently asked questions
What clinical applications is the BE Micro TREA primarily designed for, and how does it support those uses?
The BE Micro TREA is specifically designed for recording and monitoring physiological signals in neurology, with a focus on capturing EEG data. This makes it ideal for continuous assessment of brain activity during sleep studies and polysomnography, enabling detailed diagnostic evaluations in both hospital and home settings under physician supervision.
Is the BE Micro TREA intended for single-use or reusable applications, and what does this mean for maintenance?
The BE Micro TREA is supplied as a reusable device, meaning it is designed for repeated use after proper cleaning, disinfection, and maintenance. This allows for cost-effective deployment in clinical environments, though facilities must adhere to manufacturer guidelines for reprocessing to ensure safety and performance.
What features does the device include to assist clinicians during real-time monitoring?
The BE Micro TREA includes a backlit LCD display that provides real-time visualization of recording progress, impedance levels, and waveforms. This feature enhances clinician workflow by allowing immediate assessment of signal quality and patient status during monitoring sessions.
What regulatory pathways has the BE Micro TREA followed, and what does this indicate about its compliance?
The device has undergone FDA 510(k) clearance and adheres to the EU Medical Device Regulation (MDR), confirming its compliance with Class II medical device standards (regulation number 882.1400). This ensures it meets stringent safety and performance requirements for use in clinical neurology applications.
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: BE Micro - EBNeuro, BE MICRO, TREA (K093728) — FDA 510 (k) | Innolitics, BE Micro - ebneuro.com
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 | K093728 | Class II | Active |
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Manufacturer
- Manufacturer
- EB Neuro S.p.A.
Sources (3)
- FDA 510(k) K093728 24 fields · synced Sep 18, 2026
- FDA UDI 52393435-08c6-4081-8309-c78fad485100 33 fields · synced May 29, 2026
- EUDAMED e0382079-0fc9-4759-b31e-e5ed0e1769bd 61 fields · synced Jul 25, 2026