Data / Medical devices / South Korea / Wooyoung Medical Co Ltd
Wooyoung Medical Co Ltd: FDA-registered device maker in Jincheon-gun Chungbuk, South Korea, 1 510(k) clearance
Wooyoung Medical Co Ltd is registered with the FDA (registration 3009758019) in Jincheon-gun Chungbuk, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 13, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009758019
- Address
- 98, Sangsin 2-gil, Jincheon-eup, Jincheon-gun Chungbuk, South Korea, 27846
- Owner or operator
- WOO YOUNG MEDICAL CO LTD (10086818)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 14, 2022
- Registered through
- 2026
- Brand names listed
- MagiCath II
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Complaint file establishment, 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 13, 2022 | K210929 | MagiCath II | FOZ | Substantially Equivalent | Woo Young Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 13, 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.