Data / Medical devices / China / Wuxi Ea Medical Instruments Technologies Limited
Wuxi Ea Medical Instruments Technologies Limited: FDA-registered device maker in Wuxi Jiangsu, China, 3 510(k) clearances
Wuxi Ea Medical Instruments Technologies Limited is registered with the FDA (registration 3013556527) in Wuxi Jiangsu, China. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013556527
- Address
- 1F, building 1 and building 2, No. 1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi Jiangsu, China, 214174
- Owner or operator
- Wuxi EA Medical Instruments Technologies Limited (10060304)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- April 23, 2019
- Registered through
- 2026
- Brand names listed
- Aligner Chewies, Angel Aligner, Attachment Template, Clear Aligner(EAB II), Patient Kit, Removal tool, Retainer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Bracket, Orthodontic | ECQ | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Aligner, Sequential | NXC | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Dental Hygiene Kit | NXZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Indirect Bonding Tray | QJJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | 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 |
|---|---|---|---|---|---|---|
| June 13, 2023 | K223517 | Clear Aligner | NXC | Substantially Equivalent | Wuxi EA Medical Instruments Technologies Limited. | accessdata.fda.gov |
| October 8, 2021 | K203688 | Clear Aligner | NXC | Substantially Equivalent | Wuxi EA Medical Instruments Technologies Limited. | accessdata.fda.gov |
| January 19, 2018 | K171674 | Angel Align System | NXC | Substantially Equivalent | Smile Development Corp | accessdata.fda.gov |
Compare with other makers
- All makers of Aligner, Sequential
- All makers of Dental Hygiene Kit
- All makers of Clamp, Wire, Orthodontic
- All makers of Aligner, Bracket, Orthodontic
- All makers of Maintainer, Space Preformed, Orthodontic
- All makers of Indirect Bonding Tray
Updated June 13, 2023. 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.