Data / Medical devices / South Korea / Sungshim Medicare Co.,Ltd.
Sungshim Medicare Co.,Ltd.: FDA-registered device maker in Anseong-si Gyeonggi, South Korea, 2 510(k) clearances
Sungshim Medicare Co.,Ltd. is registered with the FDA (registration 3013160284) in Anseong-si Gyeonggi, South Korea. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 12, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013160284
- Address
- 81, Seomi-ro, Seoun-myeon, Anseong-si Gyeonggi, South Korea, 17608
- Owner or operator
- Sungshim Medicare Co.,Ltd. (10052486)
- Roles
- Manufacturer
- First device listed
- August 4, 2016
- Registered through
- 2026
- Brand names listed
- Sungshim Dental Needle, Sungshim sterile single use insulin pen needle, Sungshim sterile single use insulin syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Dental | DZM | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 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 |
|---|---|---|---|---|---|---|
| July 12, 2016 | K152803 | SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE | FMF | Substantially Equivalent | Sung Shim Medicare Co., Ltd. | accessdata.fda.gov |
| March 17, 2016 | K152334 | Sungshim Insulin Pen Needle | FMI | Substantially Equivalent | Sung Shim Medicare Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Needle, Dental
- All makers of Syringe, Piston
Updated July 12, 2016. 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.