Data / Medical devices / China / Sandstone Medical (suzhou) Inc.
Sandstone Medical (suzhou) Inc.: FDA-registered device maker in Suzhou Jiangsu, China, 3 510(k) clearances
Sandstone Medical (suzhou) Inc. is registered with the FDA (registration 3015955792) in Suzhou Jiangsu, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated March 25, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015955792
- Address
- Building 6, No.168 PuTuoShan Road New District, Suzhou Jiangsu, China, 215153
- Owner or operator
- Sandstone Medical (Suzhou) INC. (10080666)
- Roles
- Manufacturer
- First device listed
- February 18, 2021
- Registered through
- 2026
- Brand names listed
- Easydrip, Easydrip Classic Pen Needle, Easydrip Classic Pro Pen Needle, Easydrip Plus, Easydrip Plus Pen Needle, Easydrip Plus Pro Pen Needle, Embrace® Pen Needles, Embrace® ReadyGard Duo Safety Pen Needles and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | 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 |
|---|---|---|---|---|---|---|
| March 25, 2026 | K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle | FMI | Substantially Equivalent | Sandstone Medical (Suzhou), Inc. | accessdata.fda.gov |
| February 17, 2022 | K210864 | Safety Pen Needle | FMI | Substantially Equivalent | Sandstone Medical (Suzhou), Inc. | accessdata.fda.gov |
| February 2, 2021 | K193422 | Easydrip Pen Needle, Easydrip Plus Pen Needle | FMI | Substantially Equivalent | Sandstone Medical (Suzhou), Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 25, 2026. 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.