Sandstone Medical (Suzhou) Inc.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 1 device type, 27 products catalogued, 3 clearances.
Sandstone Medical (Suzhou) Inc. is a manufacturer holding a current FDA establishment registration. The registration covers Needle, Hypodermic, Single Lumen. 27 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
1device type
27products catalogued under its own name
3510(k) clearances
Registration
| Registered name | SANDSTONE MEDICAL (SUZHOU) INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015955792 |
| FEI number | 3015955792 |
| DUNS | 554500882 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 苏州沙力医疗器械有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Building 6, No.168 PuTuoShan Road |
| Postal code | 215153 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | Class 2 | Nano Point Pro Pen needle, Easydrip Plus Pen Needle, Easydrip Classic Pro Pen Needle, Easydrip Plus Pro Pen Needle, Easydrip Classic Pen Needle, Pen Needle and 20 more | 2021 | 71 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252908 | 2026-03-25 | FMI | Special | This company |
| K210864 | 2022-02-17 | FMI | Traditional | This company |
| K193422 | 2021-02-02 | FMI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2018 |
|---|---|
| Factory area | 12,502 m² |
| Main products | Insulin pen needles (Easydrip Classic), Insulin pen needles (Easydrip Plus), Safety pen needles (ReadyGard Duo) |
| Certifications | FDA, ISO 9001 |
| Export markets | North America, South America, Western Europe, Eastern Europe, Eastern Asia, Southeast Asia, Middle East, Africa, Oceania |
| 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.
The manufacturer named here can complete this record.