Data / Medical devices / China / Kang Ze Industrial Co., Ltd.
Kang Ze Industrial Co., Ltd.: FDA-registered device maker in Dongguan Guangdong, China, 1 510(k) clearance
Kang Ze Industrial Co., Ltd. is registered with the FDA (registration 3009518322) in Dongguan Guangdong, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 16, 2011. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009518322
- Address
- 3rd Floor, No. 21, Hongfu North Road, Qingshuiao, Jianshazhou Community, Wanjiang Street, Dongguan Guangdong, China, 523063
- Owner or operator
- KANG ZE INDUSTRIAL CO., LTD (10039351)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 29, 2011
- Registered through
- 2026
- Brand names listed
- 9028,9225A,9225B,12028,12033,233205,9225, Digital Thermometer Probe Cover 9028,9225A,9225B,12028,12033,233205,9225, Disposable Digital Oral Thermometer Sheaths 9028,9225A,9225B,12028,12033,233205,9225, Disposable Thermometer cover and probe cover; Oral Disposable Thermometer Sheaths, Probe Cover 9028,9225A,9225B,12028,12033,233205,9225
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cover, Cast | KIA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Thermometer, Clinical Mercury | FLK | 2 | 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 |
|---|---|---|---|---|---|---|
| December 16, 2011 | K112289 | DISPOSABLE THERMOMETER COVERS AND SHEATHS | FLL | Substantially Equivalent | Kang ZE Industrial Co. Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Cover, Cast
- All makers of Thermometer, Clinical Mercury
- All makers of Continuous Measurement Thermometer
Updated December 16, 2011. 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.