Data / Medical devices / South Korea / ACE MEDICAL INDUSTRy CO., LTD.
ACE MEDICAL INDUSTRy CO., LTD.: FDA-registered device maker in Yangju-si Gyeonggi, South Korea, 2 510(k) clearances
ACE MEDICAL INDUSTRy CO., LTD. is registered with the FDA (registration 3019012929) in Yangju-si Gyeonggi, South Korea. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 8, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019012929
- Address
- 57-14, Gwangjeok ro 228beon gil, Gwang jeok myeon, Yangju-si Gyeonggi, South Korea, 11414
- Owner or operator
- Ace Medical Industry Co., Ltd. (10081789)
- Roles
- Manufacturer
- First device listed
- May 16, 2021
- Registered through
- 2026
- Brand names listed
- ACE Cannula, ACE MESO THERAPIE, Cannulall, DermaFlex Aspiration Needle, Duo Cannula, Eclipse DermaFlex MicroCannula, Q Micro Cannula
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Acupuncture, Single Use | MQX | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | 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 |
|---|---|---|---|---|---|---|
| January 8, 2025 | K242741 | ACE Cannula | FMI | Substantially Equivalent | Ace Medical Industry Co., Ltd. | accessdata.fda.gov |
| November 5, 2020 | K200017 | Eclipse DermaFlex Cannula | FMI | Substantially Equivalent | Eclipse Medcorp, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Needle, Acupuncture, Single Use
- All makers of Needle, Aspiration And Injection, Disposable
Updated January 8, 2025. 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.