Data / Medical devices / China / Smart Technology Co., Ltd.
Smart Technology Co., Ltd.: FDA-registered device maker in Foshan Guangdong, China, 3 510(k) clearances
Smart Technology Co., Ltd. is registered with the FDA (registration 3012416077) in Foshan Guangdong, China. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 26, 2021. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012416077
- Address
- No. 422 Hai Tian Avenue, Gaoming District, Foshan Guangdong, China, 528500
- Owner or operator
- SMART TECHNOLOGY CO LTD (10051751)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- April 29, 2016
- Registered through
- 2026
- Brand names listed
- Digital Thermometer (DT100, TH093, TH111, TH074, TH112, TH114), EFW/TOOTHBRUSH, MANUAL, FLL/Continuous Measurement Thermometer, KCP/SYRINGE, ENT, KYX/ DISPENSER, LIQUID MEDICATION, KYZ/ SYRINGE, IRRIGATING (NON DENTAL), LKB/Pad, alcohol, device disinfectant, MEF/RING, TEETHING, NON-FLUID FILLED and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Repackager or relabeler | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 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 |
|---|---|---|---|---|---|---|
| September 26, 2021 | K203731 | DT100 Digital Thermometer | FLL | Substantially Equivalent | Smart Technology Co., Ltd. | accessdata.fda.gov |
| March 22, 2021 | K202009 | Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026 | FLL | Substantially Equivalent | Shenzhen Juzhong Technology Co., Ltd. | accessdata.fda.gov |
| August 3, 2010 | K101387 | DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN | FLL | Substantially Equivalent | Fudakang Industries Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Humidifier, Non-Direct Patient Interface (Home-Use)
- All makers of Continuous Measurement Thermometer
- All makers of Toothbrush, Manual
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Syringe, Ent
- All makers of Pad, Alcohol, Device Disinfectant
Updated September 26, 2021. 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.