FDA Registration
Active
🇨🇳 China
WUXI EA MEDICAL INSTRUMENTS TECHNOLOGIES LIMITED
Reg #: 3013556527
·
FEI: 3013556527
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- WUXI EA MEDICAL INSTRUMENTS TECHNOLOGIES LIMITED
- Registration Number
- 3013556527
- FEI Number
- 3013556527
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1F, building 1 and building 2, No. 1619, Huishan Avenue, Huishan Economic Development Zone
- City
- Wuxi Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K223517
Owner / Operator
- Firm Name
- Wuxi EA Medical Instruments Technologies Limited
- Operator Number
- 10060304
- Address
- No. 1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, China 214000
- City
- Wuxi
- State
- CN-NOTA
- Postal Code
- 214000
- Country
- CN
- Correspondent
- Jessica Luo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2026-05-17 |
| Dental Hygiene Kit | NXZ | Class 1 | Dental | No | 2025-07-29 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2023-06-19 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2025-07-15 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2020-07-09 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2025-07-15 |
Proprietary Names
Attachment Template
Patient Kit
Angel Aligner
Clear Aligner(EAB II)
Aligner Chewies
Retainer
Removal tool
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device