Data / Medical devices / China / Cea Group International Co.,ltd
Cea Group International Co.,ltd: FDA-registered device maker in Wenzhou Zhejiang, China, 1 510(k) clearance
Cea Group International Co.,ltd is registered with the FDA (registration 3014652024) in Wenzhou Zhejiang, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014652024
- Address
- Sanjiali Industrial Zone,Zhucheng Road,Panshi, Wenzhou Zhejiang, China, 325602
- Owner or operator
- CEA Group International Co.,Ltd (10095238)
- Roles
- Exporter to the US
- First device listed
- February 10, 2026
- Registered through
- 2026
- Brand names listed
- YIMI LIFE, GLOBAL INDUSTRIAL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oximeter | DQA | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| October 25, 2024 | K240092 | Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) | DQA | Substantially Equivalent | Shenzhen Yimi Life Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 25, 2024. 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.