Disposable Non-invasive EEG Sensor
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Disposable Non-invasive EEG Sensor EUDAMED
- Device Name
- Disposable Non-invasive EEG Sensor EUDAMED
- Model / Reference
- B-BIS-4A EUDAMEDB-BIS-3A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944414089906 EUDAMED06944414033503 EUDAMED
- Basic UDI-DI
- 69444140004SL EUDAMED
- 510(k) Number
- K220448 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
- EMDN Code
- N01010202 EEG EXTRACRANIC ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Neurology 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
No
Incorporates Medicinal Product
No
The Disposable Non-invasive EEG Sensor is a single-use, adhesive electrode designed for electroencephalography (EEG) recordings. It captures electrical activity from the scalp to monitor brain function without penetrating the skin, adhering to the classification of a non-invasive EEG device.
This sensor is supplied sterile and intended for single-use applications in clinical or research settings. It is classified under product code GXY and has received FDA 510(k) clearance as substantially equivalent, with regulatory compliance also confirmed under the EU Medical Device Regulation (MDR). No MRI safety information is specified, and storage conditions are not detailed in the provided data.
Frequently asked questions
What clinical settings or applications is this disposable EEG sensor primarily intended for?
This disposable non-invasive EEG sensor is designed for electroencephalography (EEG) recordings in both clinical and research environments. It captures electrical brain activity from the scalp without penetrating the skin, making it suitable for monitoring brain function in settings where non-invasive, single-use electrodes are preferred.
Is this EEG sensor reusable, or is it meant for single-use only? How does that affect its use?
The sensor is explicitly labeled for single-use only, meaning it must be discarded after one use to maintain sterility and safety. This design reduces the risk of cross-contamination and ensures consistent performance, which is particularly important in clinical settings where hygiene and reliability are critical.
How is the sensor supplied, and what does that mean for preparation before use?
The sensor is supplied sterile, which means it is pre-sterilized and ready for immediate use without additional sterilization steps. Clinicians or researchers can apply it directly to the scalp after adhering to standard EEG electrode placement protocols, ensuring a clean and safe recording environment.
Are there different sizes or models available for this EEG sensor, and if so, how might that affect selection?
The provided data does not specify multiple sizes or models for this disposable EEG sensor. Since it is a single-use, adhesive electrode designed for general non-invasive EEG recordings, selection would primarily depend on compatibility with the EEG system being used rather than varying sensor dimensions.
What regulatory pathways has this device undergone, and what does that mean for its use in the U.S. and EU?
The sensor has received FDA 510(k) clearance under the Traditional pathway, with a decision of *Substantially Equivalent* to a predicate device, and it complies with the EU Medical Device Regulation (MDR). This means it is legally marketable in both the U.S. and EU for its intended non-invasive EEG applications, provided all local regulatory requirements (e.g., labeling, distribution) are followed.
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 | K220448 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Med-Link Electronics Tech Co., Ltd.
Sources (3)
- FDA 510(k) K220448 24 fields · synced Sep 18, 2026
- EUDAMED a1a07b0b-6994-46f3-bac6-61c4d73cc72e 61 fields · synced Jul 8, 2026
- EUDAMED add37fe5-d388-4903-8e76-1e6e68481ee6 61 fields · synced Jul 31, 2026