Manufacturer registered with FDA
Wuxi EA Medical Instruments Technologies Limited
Wuxi, China. Lists 6 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 7
- 510(k) clearances
- 22021–2023
- Markets registered in
- 510 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Wuxi EA Medical Instruments Technologies Limited as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Wuxi EA Medical Instruments Technologies Limited | 2 clearances | 2021–2023 | Below |
| Taiwan | TFDA | Manufacturer | WUXIEA MEDICALINSTRUMENTS TECHNOLOGIES LIMITEDWuxi EA Medical Instruments Technologies Limited. · Wuxi EA Medical Instruments Technologies Limited | 6 | 2015–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Wuxi EA Medical Instruments Technologies Limited | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Wuxi EA Medical Instruments Technologies Limited | 1 | 2019–2019 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Wuxi EA Medical Instruments Technologies Limited. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Wuxi EA Medical Instruments Technologies Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Angel AlignerClear Aligner(EAB II) | 2019 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Retainer | 2020 |
| Orthodontic Wire ClampECN · Class 1 | — | Lister | Removal tool | 2025 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Lister | Aligner Chewies | 2025 |
| Dental Hygiene KitNXZ · Class 1 | — | Maker | Patient Kit | 2025 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | Attachment Template | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Wuxi EA Medical Instruments Technologies Limited lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Smile Development Corp (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Jan 2018 | K171674 | Angel Align System | Smile Development Corp | NXC Sequential Aligner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| WUXI EA MEDICAL INSTRUMENTS TECHNOLOGIES LIMITEDFDA reg. 3013556527 | Wuxi Jiangsu, China | Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060304). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.