Guangdong Genial Technology Co., Ltd.
Registered establishment in Zhaoqing, Guangdong, China. 5 device types, 5 clearances.
Guangdong Genial Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Clinical Electronic Thermometer and 3 other device types. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | GUANGDONG GENIAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016670149 |
| FEI number | 3016670149 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 广东健奥科技有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Zhaoqing |
|---|---|
| Province | Guangdong |
| Address | I-6-05-02,11th Road, Area B, Guanfozhao Economic Cooperation Zone, Zhagang Town, Huaiji County |
| Postal code | 526437 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clinical Electronic Thermometer | Class 2 | T23, T24, T25, T26, T28, T28L, T28P, Models: T11,T11L,T12,T12C,T12D,T12E,T12L,T14,T14H,T15,T15B,T15ST15SC,T15SL,T16,T17,T17L,T18,T18B,T18C,T19,T19B,T19C,T19D | 2025 | 49 |
| Continuous Measurement Thermometer | Class 2 | Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85, T86, T87), Wearable Digital Thermometer, Model: T31 | 2021 | 115 |
| Oximeter | Class 2 | Finger Clip Pulse Oximeter, Model:GX3, GX5, GX7, GX9, GX11, GX13.GX4, GX6, GX8, GX10, GX12, GX14 | 2023 | 70 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | 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, 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 | 2023 | 98 |
| Thermometer, Clinical Color Change | Class 1 | Thermometer | 2020 | 15 |
Clearances
5 clearances name Guangdong Genial Technology Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240333 | 2024-10-30 | FLL | Traditional | This company |
| K232678 | 2024-01-31 | FLL | Traditional | This company |
| K231250 | 2023-11-28 | DXN | Traditional | This company |
| K231245 | 2023-11-22 | DXN | Traditional | This company |
| K231243 | 2023-10-31 | DQA | Traditional | This company |
| K210014 | 2021-06-04 | FLL | Traditional | Guandong Genial Technology Co., Limited |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Factory area | 45000 m² |
| Main products | Digital thermometers, Blood pressure monitors, Infrared thermometers, Nebulizers, Oximeters |
| Certifications | ISO13485, ISO45001, ISO14001, BSCI, TUV, SGS |
| Export markets | 117+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Guangdong Marshell Electric Vehicle Co., Ltd. | 22 |
| Guangdong Kangshen Medical Technology Co., Ltd. | 12 |
| Coray Medical Co., Ltd. | 4 |
| Guangdong Huankai Biology SCI.&Tech.co., Ltd. | 2 |
| Yijia Optical Technology (Zhaoqing Huaiji) Co., Ltd. | 2 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.