Data / Medical devices / China / Shanghai Handy Medical Equipment Co., Ltd.
Shanghai Handy Medical Equipment Co., Ltd.: FDA-registered device maker in Shanghai, China, 1 510(k) clearance
Shanghai Handy Medical Equipment Co., Ltd. is registered with the FDA (registration 3013039893) in Shanghai, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 22, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013039893
- Address
- Bldg No.11, Lane 177, Fulian Er Road Baoshan District, Shanghai, China, 201906
- Owner or operator
- Shanghai Handy Medical Equipment Co., Ltd. (10054306)
- Roles
- Manufacturer
- First device listed
- December 4, 2020
- Registered through
- 2026
- Brand names listed
- HDI-210, HDI-200A, HDI-220D, HDI-220DA, HDI-712C. HDI-712D, HDR Sensor, HDR-361, HDR-461, Intraroral Camera
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 22, 2022 | K221008 | HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) | MUH | Substantially Equivalent | Shanghai Handy Medical Equipment Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of Unit, Operative Dental, Accessories
Updated June 22, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.