Data / Medical devices / China / Cotronic Technology Limited
Cotronic Technology Limited: FDA-registered device maker in SHENZHEN, GUANG DONG PROVINCE Guangdong, China, 3 510(k) clearances
Cotronic Technology Limited is registered with the FDA (registration 3004215929) in SHENZHEN, GUANG DONG PROVINCE Guangdong, China. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 17, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004215929
- Address
- Floor 4-6, Block 7, West of ZhouShi Road XiXiang Street, BaoAn Zone, SHENZHEN, GUANG DONG PROVINCE Guangdong, China, 518126
- Owner or operator
- COTRONIC TECHNOLOGY LIMITED (9057884)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 14, 2003
- Registered through
- 2026
- Brand names listed
- ASPI, ASPI 2, ASPI 3, ASPI 4, ASPI 5, ASPI-V, CR01, CR02, CR03, CR04, CR05, CR06, CR07, CR08, CR09, CR10, Clinical Electronic Thermometer Model TM12 & TM21, Clinical Electronic Thermometer Model TM12 & TM21; TM22, Clinical Electronic Thermometer Model TM22, DIGITAL ELECTRONIC THERMOM, Digital Soother Thermometer model TM03, Digital soother thermometer model TM03 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dilator, Rectal | FFP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Irrigator, Powered Nasal | KMA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| May 17, 2013 | K120671 | DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) | FLL | Substantially Equivalent | Cotronic Technology Limited | accessdata.fda.gov |
| May 13, 2011 | K103407 | COTRONIC DIGITAL THERMOMETER | FLL | Substantially Equivalent | Cotronic Manufacturing | accessdata.fda.gov |
| December 27, 2004 | K032434 | CLINICAL ELECTRONIC THERMOMETER | FLL | Substantially Equivalent | Cotronic Manufacturing | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Dilator, Rectal
- All makers of Clinical Electronic Thermometer
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Irrigator, Powered Nasal
Updated May 17, 2013. 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.