FDA Registration
Active
🇨🇳 China
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
Reg #: 3016670149
·
FEI: 3016670149
·
Expires 2026
Products
5
Proprietary Names
10
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- GUANGDONG GENIAL TECHNOLOGY CO., LTD.
- Registration Number
- 3016670149
- FEI Number
- 3016670149
- Status
- Active
- Expiry Year
- 2026
- 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
- K240333
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 |
|---|---|---|---|---|---|
| Thermometer, Clinical Color Change | FQZ | Class 1 | General Hospital | No | 2020-05-01 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-06-25 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-11-14 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-12-02 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-12-02 |
Proprietary Names
Thermometer
Models: T11,T11L,T12,T12C,T12D,T12E,T12L,T14,T14H,T15,T15B,T15ST15SC,T15SL,T16,T17,T17L,T18,T18B,T18C,T19,T19B,T19C,T19D
T23, T24, T25, T26, T28, T28L, T28P
Wearable Digital Thermometer, Model: T31
Finger Clip Pulse Oximeter, Model:GX3, GX5, GX7, GX9, GX11, GX13.GX4, GX6, GX8, GX10, GX12, GX14
Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85, T86, T87)
Digital Blood Pressure Monitor, Model GT-701,GT-701B,GT-701C,GT-701D,GT-701E,GT-701F,GT-701L
Digital Blood Pressure Monitor (Arm Type), Model:GT-702, GT-702B, GT-702C, GT-702E, GT-712, GT-712C, GT-712B
GT-712E, GT-722, GT-722B, GT-722C, GT-732, GT-732B, GT-732C, GT-732D, GT-702V
GT-702D, GT-702M, GT-702MB, GT-702L, GT-702LP, GT-702CM, GT-732M, GT-702BM, GT-702CP
Establishment Types
Manufacture Medical Device