Data / Medical devices / South Korea / Sooil Development Co., Ltd.
Sooil Development Co., Ltd.: FDA-registered device maker in Yongin-si Gyeonggi, South Korea, 4 510(k) clearances
Sooil Development Co., Ltd. is registered with the FDA (registration 9616814) in Yongin-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 4, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616814
- FEI number
- 3003024060
- Address
- 62, Yonggu-daero 2325beon-gil, Giheung-gu, Yongin-si Gyeonggi, South Korea, 16922
- Owner or operator
- SOOIL DEVELOPMENT CO., LTD. (9041551)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 16, 2008
- Registered through
- 2026
- Brand names listed
- DANA 3CC SYRINGE INSULIN RESERVOIR, DANA DIABECARE II INSULIN PUMP, DANA DIABECARE IIS, DANA DIABECARE INSULIN PUMP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Pump, Infusion | MRZ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pump, Infusion, Insulin | LZG | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| September 4, 2007 | K071418 | DANA 3CC SYRINGE INSULIN RESERVOIR | MRZ | Substantially Equivalent | Sooil Development Co., Ltd. | accessdata.fda.gov |
| February 2, 2007 | K063126 | DANA DIABECARE IIS | LZG | Substantially Equivalent | Sooil Development Co., Ltd. | accessdata.fda.gov |
| August 2, 2002 | K022317 | DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS | LZG | Substantially Equivalent | Sooil Development Co., Ltd. | accessdata.fda.gov |
| August 14, 2000 | K001604 | DANA DIABECARE | LZG | Substantially Equivalent | Sooil Development Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 4, 2007. 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.