FDA Registration
Active
🇨🇳 China
Finger Clip Pulse Oximeter, Model:GX3, GX5, GX7, GX9, GX11, GX13.GX4, GX6, GX8, GX10, GX12, GX14
Reg #: 3016670149
·
FEI: 3016670149
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GUANGDONG GENIAL TECHNOLOGY CO., LTD.
- Registration Number
- 3016670149
- FEI Number
- 3016670149
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- I-6-05-02,11th Road, Area B, Guanfozhao Economic Cooperation Zone, Zhagang Town, Huaiji County
- City
- Zhaoqing Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K231243
Owner / Operator
- Firm Name
- Guangdong Genial Technology CO., Ltd.
- Operator Number
- 10072762
- Address
- I-6-05-02,11th Road, Area B, Guanfozhao Economic Cooperation Zone, Zhagang Town, Huaiji County
- City
- Zhaoqing
- State
- Guangdong
- Postal Code
- 526437
- Country
- CN
- Correspondent
- Yu Jun
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-12-02 |
Proprietary Names
Finger Clip Pulse Oximeter, Model:GX3, GX5, GX7, GX9, GX11, GX13.GX4, GX6, GX8, GX10, GX12, GX14
Establishment Types
Manufacture Medical Device