Data / Medical devices / Japan / Togo Medikit Co., Ltd. Medikit Hyuga Second Factory
Togo Medikit Co., Ltd. Medikit Hyuga Second Factory: FDA-registered device maker in Hyuga City Miyazaki, Japan, 3 510(k) clearances
Togo Medikit Co., Ltd. Medikit Hyuga Second Factory is registered with the FDA (registration 3014270673) in Hyuga City Miyazaki, Japan. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated September 20, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014270673
- Address
- 435-3, Hei, Aza Kakinokida, Yamage, Togo-cho, Hyuga City Miyazaki, Japan, 883-0102
- Owner or operator
- TOGO MEDIKIT CO., LTD. (8030371)
- Roles
- Manufacturer
- First device listed
- September 12, 2014
- Registered through
- 2026
- Brand names listed
- Supercath 5, Supercath5
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 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 |
|---|---|---|---|---|---|---|
| September 20, 2019 | K190001 | Supercath 5 | FOZ | Substantially Equivalent | Togo Medikit Co., Ltd. | accessdata.fda.gov |
| March 23, 2018 | K172496 | SUPERCATH 5 (26G) | FOZ | Substantially Equivalent | Togo Medikit Co., Ltd. | accessdata.fda.gov |
| May 12, 2014 | K140419 | SUPERCATH5 | FOZ | Substantially Equivalent | Togo Medikit Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 20, 2019. 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.