Data / Medical devices / China / Guangdong Genial Technology Co., Ltd.
Guangdong Genial Technology Co., Ltd.: FDA-registered device maker in Zhaoqing Guangdong, China, 5 510(k) clearances
Guangdong Genial Technology Co., Ltd. is registered with the FDA (registration 3016670149) in Zhaoqing Guangdong, China. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 30, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016670149
- Address
- I-6-05-02,11th Road, Area B, Guanfozhao Economic Cooperation Zone, Zhagang Town, Huaiji County, Zhaoqing Guangdong, China, 526437
- Owner or operator
- Guangdong Genial Technology CO., Ltd. (10072762)
- Roles
- Manufacturer
- First device listed
- May 1, 2020
- Registered through
- 2026
- Brand names listed
- Digital Blood Pressure Monitor (Arm Type), Model:GT-702, GT-702B, GT-702C, GT-702E, GT-712, GT-712C, GT-712B, Digital Blood Pressure Monitor, Model GT-701,GT-701B,GT-701C,GT-701D,GT-701E,GT-701F,GT-701L, Finger Clip Pulse Oximeter, Model:GX3, GX5, GX7, GX9, GX11, GX13.GX4, GX6, GX8, GX10, GX12, GX14, GT-702D, GT-702M, GT-702MB, GT-702L, GT-702LP, GT-702CM, GT-732M, GT-702BM, GT-702CP, GT-712E, GT-722, GT-722B, GT-722C, GT-732, GT-732B, GT-732C, GT-732D, GT-702V, Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85, T86, T87), 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, T1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
| Thermometer, Clinical Color Change | FQZ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 30, 2024 | K240333 | Wearable Digital Thermometer (T31) | FLL | Substantially Equivalent | Guangdong Genial Technology Co., Ltd. | accessdata.fda.gov |
| November 28, 2023 | K231250 | Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Genial Technology Co., Ltd. | accessdata.fda.gov |
| November 22, 2023 | K231245 | Digital Blood Pressure Monitor (Arm Type) | DXN | Substantially Equivalent | Guangdong Genial Technology Co., Ltd. | accessdata.fda.gov |
| October 31, 2023 | K231243 | Finger Clip Pulse Oximeter | DQA | Substantially Equivalent | Guangdong Genial Technology Co., Ltd. | accessdata.fda.gov |
| June 4, 2021 | K210014 | Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) | FLL | Substantially Equivalent | Guandong Genial Technology Co., Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Oximeter
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Thermometer, Clinical Color Change
- All makers of Clinical Electronic Thermometer
Updated October 30, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.