Shanghai EA Medical Instruments Co., Ltd.
Manufacturer and brand owner in Yangpu District, Shanghai, China. 1 device type, 1 product catalogued, 1 clearance.
Shanghai EA Medical Instruments Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Orthodontic Software. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
1device type
1product
1510(k) clearance
Registration
| Registered name | SHANGHAI EA MEDICAL INSTRUMENTS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016730274 |
| FEI number | 3016730274 |
| DUNS | 544344306 |
| Establishment type | Manufacturer |
Location
| City | Yangpu District |
|---|---|
| Province | Shanghai |
| Address | Room 601-603, No. 500, Zhengli Road |
| Postal code | 201615 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Orthodontic Software | Class 2 | 2023 | 4 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Angel Aligner | PNN | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K223518 | 2023-06-13 | PNN | Traditional | This company |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.