Data / Medical devices / South Korea / Jeil Tech Co.,ltd
Jeil Tech Co.,ltd: FDA-registered device maker in Sejong-si Daegu, South Korea, 1 510(k) clearance
Jeil Tech Co.,ltd is registered with the FDA (registration 3007774504) in Sejong-si Daegu, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 19, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007774504
- Address
- 190, Maesil-ro, Sojeong-myeon, Sejong-si Daegu, South Korea, 339871
- Owner or operator
- JEIL TECH Co.,Ltd (10042692)
- Roles
- Manufacturer
- First device listed
- April 3, 2023
- Registered through
- 2026
- Brand names listed
- CHOICARE Sterile Single-use LDV Syringe, Sterile Single-use LDV Syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Low Dead Space Piston Syringe | QNQ | 2 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| September 19, 2022 | K213013 | Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe | QNQ | Substantially Equivalent | Jeil Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 19, 2022. 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.