Cotronic Technology Limited
Registered establishment in Shenzhen, Guang Dong, Guangdong, China. 5 device types, 1 clearance.
Cotronic Technology Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Dilator, Rectal, Irrigator, Powered Nasal and 3 other device types. Its earliest product listing with the FDA dates from 2003.
Registration
| Registered name | COTRONIC TECHNOLOGY LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004215929 |
| FEI number | 3004215929 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 群力科技有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Shenzhen, Guang Dong |
|---|---|
| Province | Guangdong |
| Address | Floor 4-6, Block 7, West of ZhouShi Road |
| Postal code | 518126 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clinical Electronic Thermometer | Class 2 | Clinical Electronic Thermometer Model TM12 & TM21; TM22, TM01, TM02, TM03, TM08, TM09S, TM12, TM21, TM22, MT201, MT803, MT804, Digital Soother Thermometer model TM03 | 2025 | 49 |
| Continuous Measurement Thermometer | Class 2 | Digital Electronic Thermom, TM01, TM02/ TM08, TM09S, TM12FE, TM12F, MT804, TM13, Digital soother thermometer model TM03, Clinical Electronic Thermometer Model TM22, Clinical Electronic Thermometer Model TM12 & TM21 | 2003 | 115 |
| Dilator, Rectal | Class 1 | Gas Evacuation Tube, CR01, CR02, CR03, CR04, CR05, CR06, CR07, CR08, CR09, CR10 | 2023 | 3 |
| Irrigator, Powered Nasal | Class 1 | NI01, NI02, NI03, NI04, NI05, NI06, NI07, NI08, NI09, NI10, Nasal Irrigation | 2023 | 63 |
| Syringe, Irrigating (Non Dental) | Class 1 | Nasal Aspirator, Aspi, Aspi 2, Aspi 3, Aspi 4, Aspi 5, Aspi-V | 2018 | 110 |
Clearances
1 clearance names Cotronic Technology Limited as applicant. 2 are 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 |
|---|---|---|---|---|
| K120671 | 2013-05-17 | FLL | Traditional | This company |
| K103407 | 2011-05-13 | FLL | Traditional | Cotronic Manufacturing |
| K032434 | 2004-12-27 | FLL | Traditional | Cotronic Manufacturing |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1996 |
|---|---|
| Main products | Digital thermometers, Hygro-thermometers, Pedometers, Cyclocomputers, Temperature modules |
| Certifications | ISO 9001, ISO 14001, ISO 13485, CE, FDA |
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.