Smart Technology Co., Ltd.
Registered establishment in Foshan, Guangdong, China. 9 device types, 1 clearance.
Smart Technology Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Syringe, Ent, Toothbrush, Manual and 7 other device types. Its earliest product listing with the FDA dates from 2016.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3012416077 |
| FEI number | 3012416077 |
| Establishment type | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
Location
| City | Foshan |
|---|---|
| Province | Guangdong |
| Address | No. 422 Hai Tian Avenue, Gaoming District |
| Postal code | 528500 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Continuous Measurement Thermometer | Class 2 | Digital Thermometer (DT100, TH093, TH111, TH074, TH112, TH114), FLL/Continuous Measurement Thermometer, Probe Cover | 2020 | 115 |
| Dispenser, Liquid Medication | Class 1 | KYX/ Dispenser, Liquid Medication | 2019 | 86 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | Class 1 | 2016 | 55 | |
| Pad, Alcohol, Device Disinfectant | Class U | LKB/Pad, alcohol, device disinfectant | 2019 | 49 |
| Ring, Teething, Non-Fluid Filled | Class 1 | MEF/Ring, Teething, NON-Fluid Filled | 2025 | 42 |
| Stethoscope, Manual | Class 1 | Olympus 1 | 2025 | 64 |
| Syringe, Ent | Class 1 | KCP/Syringe, ENT | 2020 | 24 |
| Syringe, Irrigating (Non Dental) | Class 1 | KYZ/ Syringe, Irrigating (NON Dental) | 2019 | 110 |
| Toothbrush, Manual | Class 1 | EFW/Toothbrush, Manual | 2019 | 244 |
Clearances
1 clearance names Smart Technology Co., Ltd. as applicant. 2 are held by other companies 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 |
|---|---|---|---|---|
| K203731 | 2021-09-26 | FLL | Traditional | This company |
| K202009 | 2021-03-22 | FLL | Traditional | Shenzhen Juzhong Technology Co., Ltd. |
| K101387 | 2010-08-03 | FLL | Traditional | Fudakang Industries Co., Ltd. |
Nearby Manufacturers
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.