FDA Registration
Active
🇨🇳 China
Amydi-med Disposable Non-invasive EEG electrodes AMD-DE-PF0001-1
Reg #: 3016509765
·
FEI: 3016509765
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- shenzhen Amydi-med Electrics Tech Co., Ltd.
- Registration Number
- 3016509765
- FEI Number
- 3016509765
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 601, No.15 Building, Xianan No. 3 Industrial Zone, Shangcun, Gongming Street, Guangming District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240668
Owner / Operator
- Firm Name
- Shenzhen Amydi-med Electrics Tech Co.,Ltd
- Operator Number
- 10062200
- Address
- No.15 Building, Xianan No.3 Indusrial Zone, Shangcun, Gongming , Guangming District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518106
- Country
- CN
- Correspondent
- Shuqin Zhong
US Agent
- Business Name
- GVM MEDICAL LLC
- Contact Name
- Maple Chen
- Address
- 101 Linden Wood Drive, Suite 225
- City
- Malvern
- State
- PA
- ZIP
- 19355
- Country
- US
- [email protected]
- Phone
- 610 4517988
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2024-03-31 |
Proprietary Names
Amydi-med Disposable Non-invasive EEG electrodes AMD-DE-PF0001-1
Amydi-med Disposable Non-invasive EEG electrodes AMD-DE-AF0005-1
Amydi-med Disposable Non-invasive EEG electrodes AMD-DE-AF0004-1
Amydi-med Disposable Non-invasive EEG electrodes AMD-DE-AF0007-1
Amydi-med Disposable Non-invasive EEG electrodes AMD-DE-AF0001-1
Amydi-med Disposable Non-invasive EEG electrodes AMD-DE-PF0004-1
Amydi-med Disposable Non-invasive EEG electrodes AMD-DE-AF0003-1
Amydi-med Disposable Non-invasive EEG electrodes AMD-DE-AF0002-1
Amydi-med Disposable Non-invasive EEG electrodes AMD-DE-AF0006-1
Establishment Types
Manufacture Medical Device