Amydi-med Disposable Non-invasive EEG Electrodes (GXY)
by Shenzhen Amydi-med Electrics Tech Co., Ltd
510(k) K240668
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK240668 | Date19 Mar 2024 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Amydi-med Disposable Non-invasive EEG electrodes
- 510(k) Number
- FDA Product Code
- GXY
- FDA applicant
- Shenzhen Amydi-Med Electrics Tech Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Amydi-med Disposable Non-invasive EEG Electrodes (GXY) are classified as disposable, non-invasive electrodes designed for electroencephalography (EEG) monitoring. These electrodes facilitate the recording of electrical activity in the brain by adhering to the scalp, enabling real-time assessment of neurological function in clinical settings.
These electrodes are supplied as single-use, sterile devices intended for use in perioperative and intensive care environments. Compatible with multiple anesthesia depth monitors and patient monitoring systems, they adhere to FDA 510(k) and MDR regulatory standards. Storage and handling must follow manufacturer guidelines to maintain sterility and functionality, ensuring reliable performance in diagnostic and procedural contexts.
From the manufacturer
EEG Sensor Manufacturer Amydi-med Disposable non-Invasive EEG Sensor/Electrodes obtained CE and ISO 13485 certificates, could compatible with BIS, Masimo, Quantium, SWT, Grow Young, Sosiha, Newsky patient monitors. The EEG Sensor used with interface cable and anesthesia depth monitor.
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Questions
AI-generated answers, 18 Sep 2026
Are these EEG electrodes reusable or designed for single-use only, and how does that affect their clinical use?
These electrodes are explicitly designed for single-use only, as stated in the description. This ensures sterility and reduces the risk of cross-contamination, which is particularly important in perioperative and intensive care settings where hygiene is critical. Single-use also eliminates the need for cleaning or reprocessing, simplifying workflow and ensuring consistent performance for each patient.
What types of clinical environments or procedures are these electrodes intended for, and why?
The electrodes are intended for perioperative and intensive care environments, as noted in the description. These settings require reliable, non-invasive monitoring of brain activity during surgeries or critical care, where real-time EEG data helps assess neurological function and guide clinical decisions. Their disposable, sterile design aligns with the high-hygiene standards of these environments.
How should these electrodes be stored to maintain their sterility and functionality?
The manufacturer’s guidelines must be followed for storage and handling to preserve sterility and functionality, as emphasized in the description. Proper storage ensures the electrodes remain effective for their intended use in EEG monitoring, preventing degradation or contamination that could compromise diagnostic accuracy.
Are these electrodes compatible with specific anesthesia depth monitors or patient monitoring systems?
Yes, the electrodes are compatible with multiple anesthesia depth monitors and patient monitoring systems, as stated in the description. This versatility allows them to integrate seamlessly with existing clinical infrastructure, ensuring broad applicability in EEG-based neurological assessments during procedures or critical care.