Data / Medical devices / South Korea / Tae-Chang Industrial Co., Ltd.
Tae-Chang Industrial Co., Ltd.: FDA-registered device maker in Gumi-si Gyeongbuk, South Korea, 3 510(k) clearances
Tae-Chang Industrial Co., Ltd. is registered with the FDA (registration 3011676762) in Gumi-si Gyeongbuk, South Korea. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated June 27, 2018. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011676762
- Address
- 127, Sanho-daero, Gumi-si Gyeongbuk, South Korea, 39378
- Owner or operator
- Tae-Chang Industrial Co., Ltd. (9062236)
- Roles
- Contract sterilizer, Manufacturer
- First device listed
- February 5, 2008
- Registered through
- 2026
- Brand names listed
- CAREFINE PEN NEEDLE, CVS TRUEplus 50CT 5 bevel Sterile pen needles, Exel Spinal Needles, Insuflo, Insuflo Quinta, Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel, TRUEplus 3 bevel Sterile pen needles and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Contract sterilizer, 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 |
|---|---|---|---|---|---|---|
| June 27, 2018 | K180720 | Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel | FMI | Substantially Equivalent | Medibio USA, LLC | accessdata.fda.gov |
| September 12, 2017 | K171144 | Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel | FMI | Substantially Equivalent | Medbio, LLC | accessdata.fda.gov |
| January 23, 2014 | K133100 | CAREFINE PEN NEEDLE | FMI | Substantially Equivalent | Facet Technologies | accessdata.fda.gov |
Compare with other makers
Updated June 27, 2018. 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.