Shanghai Handy Medical Equipment Co., Ltd.
Registered establishment in Shanghai, China. 2 device types, 1 clearance.
Shanghai Handy Medical Equipment Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Unit, Operative Dental, Accessories, System, X-Ray, Extraoral Source, Digital. Its earliest product listing with the FDA dates from 2020.
2device types registered with the FDA
1510(k) clearance
Registration
| Registered name | SHANGHAI HANDY MEDICAL EQUIPMENT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013039893 |
| FEI number | 3013039893 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 上海汉缔医疗设备有限公司 |
|---|---|
| Unified social credit code | 91310113674634659X |
| Source | NMPA UDI database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Bldg No.11, Lane 177, Fulian Er Road |
| Postal code | 201906 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | Class 2 | HDR Sensor, HDR-461, HDR-361 | 2022 | 10 |
| Unit, Operative Dental, Accessories | Class 1 | Intraroral Camera, HDI-210, HDI-200A, HDI-220D, HDI-220DA, HDI-712C. HDI-712D | 2020 | 65 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K221008 | 2022-06-22 | MUH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Oral endoscope, Image sensors, Oral digital imaging products |
|---|---|
| Export markets | Europe, America, Japan, Korea |
| OEM and ODM | Offered |
Nearby Manufacturers
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.
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