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US
Last updated May 30, 2026
What Wuxi EA Medical Instruments Technologies Limited. makes
Wuxi EA Medical Instruments Technologies Limited manufactures orthodontic progressive aligners, including custom-fitted dental devices designed to gradually shift teeth into alignment. Their product line includes aligner systems such as the angel aligner Classic, IMPRESS, and generic Clear Aligner variants, which are intended for use in orthodontic treatment plans.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s 510(k) and UDI registries. The company operates from the United States, adhering to applicable medical device regulations for aligner-based orthodontic solutions.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Wuxi EA Medical Instruments Technologies Limited manufacture?
Wuxi EA Medical Instruments Technologies Limited specializes in orthodontic progressive aligners. These are custom-fitted dental devices designed to gradually move teeth into proper alignment as part of orthodontic treatment plans. Examples include the angel aligner Classic, IMPRESS, and generic Clear Aligner variants.
Where is Wuxi EA Medical Instruments Technologies Limited based?
The company is based in the United States. This location ensures compliance with U.S. medical device regulations, including those governing orthodontic aligners.
Which regulatory registries list Wuxi EA Medical Instruments Technologies Limited’s devices?
The company’s orthodontic progressive aligners are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the necessary regulatory pathways for Class II classification.
How are Wuxi EA Medical Instruments Technologies Limited’s devices classified under medical device regulations?
The company’s orthodontic progressive aligners fall under Class II classification. This classification is determined by regulatory authorities based on the device’s intended use and risk level, requiring special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 421315681
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| angel aligner Classic | EAB II | FDA UDI | Class II | Active |
| Impress | EAB II | FDA UDI | Class II | Active |
| angel aligner | EAB II | FDA UDI | Class II | Active |
| Clear Aligner | K223517 | FDA 510(k) | Class II | Active |
| Clear Aligner | K203688 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Wuxi Ea Medical Instruments Technologies Limited Wuxi Jiangsu · CN FEI 3013556527