Data / Medical devices / South Korea / Shina Med Corporation
Shina Med Corporation: FDA-registered device maker in Anseong-si Gyeonggi, South Korea, 6 510(k) clearances
Shina Med Corporation is registered with the FDA (registration 3004458481) in Anseong-si Gyeonggi, South Korea. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004458481
- Address
- 455-30, Bogaewonsam-ro Bogae-myeon, Anseong-si Gyeonggi, South Korea, 17509
- Owner or operator
- SHINA MED CORPORATION (10048989)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 28, 2016
- Registered through
- 2026
- Brand names listed
- DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES, Shina Syringe, Shina Safety Syringe, Sure-Fine Insulin Syringes, SureFine Pen Needle, SureSwab (SureSwab NP, SureSwab OP, SureSwab Dual), ULTICARE DISPOSABLE SYRINGES AND NEEDLES, ULTICARE SAFETY INSULIN SYRINGE, ULTIMED ULTICARE SAFETY SYRINGE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| October 15, 2025 | K250510 | Sure-Fine Insulin Syringes | FMF | Substantially Equivalent | Shina Med Corporation | accessdata.fda.gov |
| April 3, 2025 | K250658 | SureFine Pen Needle | FMI | Substantially Equivalent | Shina Med Corporation | accessdata.fda.gov |
| October 27, 2023 | K231165 | Shina Syringe; Shina Safety Syringe | MEG | Substantially Equivalent | Shina Med Corporation | accessdata.fda.gov |
| September 6, 2019 | K191531 | Sure-Fine Insulin Syringes | FMF | Substantially Equivalent | Shina Med Corporation | accessdata.fda.gov |
| September 9, 2016 | K152879 | Sure-Fine Insulin Syringes | FMF | Substantially Equivalent | Shina Med Corporation | accessdata.fda.gov |
| June 7, 2016 | K152877 | SureFine Pen Needle | FMI | Substantially Equivalent | Shina Med Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
- All makers of Applicator, Absorbent Tipped, Sterile
Updated October 15, 2025. 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.