Data / Medical devices / South Korea / Ap MDS Co.,ltd.
Ap MDS Co.,ltd.: FDA-registered device maker in Incheon, South Korea, 1 510(k) clearance
Ap MDS Co.,ltd. is registered with the FDA (registration 3030970103) in Incheon, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 30, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030970103
- Address
- 5F, 39-36, Nonhyeon-ro 46beon-gil, Namdong-gu, Incheon, South Korea, 21655
- Owner or operator
- AP MDS Co.,Ltd. (10083007)
- Roles
- Manufacturer
- First device listed
- October 20, 2021
- Registered through
- 2026
- Brand names listed
- Silicone Bandage, Two-way and Three-way Disposable Silicone Foley catheters
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | 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 |
|---|---|---|---|---|---|---|
| December 30, 2020 | K201776 | Foley Balloon Catheter for Urology | EZL | Substantially Equivalent | Apollon Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 30, 2020. 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.