Data / Medical devices / South Korea / Yong Chang Co., Ltd.
Yong Chang Co., Ltd.: FDA-registered device maker in Gimpo Gyeonggi, South Korea, 2 510(k) clearances
Yong Chang Co., Ltd. is registered with the FDA (registration 3017717188) in Gimpo Gyeonggi, South Korea. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 29, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017717188
- Address
- 16, Hwanggeum-Ro 292beon-Gil Yangchon-Eup, Gimpo Gyeonggi, South Korea, 10049
- Owner or operator
- YONG CHANG Co., Ltd. (10078365)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 20, 2020
- Registered through
- 2026
- Brand names listed
- DermiSync, MINT MICROCANNULA, OSG CANNULA, PD NANO CANNULA, PD NANO NEEDLES, PRIME SYRINGE, SHARP NEEDLE, SHARP NEEDLES
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Contract manufacturer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Contract manufacturer | accessdata.fda.gov |
| Culture Media, Non-Selective And Differential | JSH | 1 | Contract manufacturer | accessdata.fda.gov |
| Culture Media, Non-Selective And Non-Differential | JSG | 1 | Contract manufacturer | accessdata.fda.gov |
| Culture Media, Selective And Differential | JSI | 1 | Contract manufacturer | accessdata.fda.gov |
| Culture Media, Selective And Non-Differential | JSJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Contract manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer, 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 29, 2016 | K162180 | Disposable Insulin Syringe | FMF | Substantially Equivalent | Berpu Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 21, 2016 | K151090 | CPL Insulin Pen Needle | FMI | Substantially Equivalent | Cpl Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Antistick
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Syringe, Piston
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Culture Media, Non-Selective And Differential
- All makers of Culture Media, Selective And Differential
Updated December 29, 2016. 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.