Data / Medical devices / South Korea / W.l.med Co., Ltd.
W.l.med Co., Ltd.: FDA-registered device maker in Anseong-si Gyeonggi, South Korea, 2 510(k) clearances
W.l.med Co., Ltd. is registered with the FDA (registration 3020138744) in Anseong-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 25, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3020138744
- Address
- 246, Geumgwangosan-ro Geumgwang-myeon, Anseong-si Gyeonggi, South Korea, 17535
- Owner or operator
- W.L.Med Co., Ltd. (10082898)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 12, 2021
- Registered through
- 2027
- Brand names listed
- Sure-Fine Insulin Syringes, SureFine Pen Needle, Well-life Pen Needles, Well-life Safety Pen Needles
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| May 25, 2022 | K210748 | Well-life TM Pen Needles, Well-life TM Safety Pen Needles | FMI | Substantially Equivalent | W. L. Med Co., Ltd. | accessdata.fda.gov |
| March 1, 2022 | K210848 | Sure-Fine Insulin Syringes | FMF | Substantially Equivalent | Shina Med Corporation | accessdata.fda.gov |
Compare with other makers
Updated May 25, 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.