Data / Medical devices / South Korea / Medifirst Co.,Ltd.
Medifirst Co.,Ltd.: FDA-registered device maker in Cheonan-si, Chungnam, South Korea, 3 510(k) clearances
Medifirst Co.,Ltd. is registered with the FDA (registration 3010384323) in Cheonan-si, Chungnam, South Korea. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 23, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010384323
- Address
- 1049-16, Charyeonggogae-ro Gwangdeok-myeon, Dongnam-gu, Cheonan-si, Chungnam, South Korea, 330922
- Owner or operator
- MediFirst Co.,Ltd. (10043739)
- Roles
- Manufacturer
- First device listed
- March 18, 2013
- Registered through
- 2026
- Brand names listed
- ESR GRAPHENE MARATHON Face Mask/MF-KIP-007(L), MF-KIP-008(M), MF-KIP-009(S), Feel Fine Insulin pen needle, Feel-Ject Insulin syringe, MEDI HIT Face Mask(KF94)/MF-KF94-007(L), MF-KF94-008(M), MF-KF94-009(S), MEDI HIT Face Mask/MF-KFAD-007(L), MF-KFAD-008(M), MF-KFAD-009(S), MF Reagents (MF C001, MF C002, MF C003, MF C004, MF C005), MF SAFECATH, RED SHIELD Face Mask(KF-80)/MF-KF80-001(L), MF-KF80-002(M), MF-KF80-003(S) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Sterile | KDT | 1 | Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 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 |
|---|---|---|---|---|---|---|
| April 23, 2020 | K192230 | MF SAFECATH | FOZ | Substantially Equivalent | Medifirst Co., Ltd. | accessdata.fda.gov |
| June 4, 2008 | K080904 | FEEL-FINE INSULIN PEN NEEDLE | FMI | Substantially Equivalent | Feel Tech | accessdata.fda.gov |
| June 20, 2007 | K070917 | FEEL-JECT INSULIN SYRINGE | FMF | Substantially Equivalent | Feel Tech | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Syringe, Piston
- All makers of Container, Specimen Mailer And Storage, Sterile
- All makers of Needle, Hypodermic, Single Lumen
Updated April 23, 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.