Data / Medical devices / Japan / Menicon Co., Ltd., Seki Plant
Menicon Co., Ltd., Seki Plant: FDA-registered device maker in Seki Gifu, Japan, 1 510(k) clearance
Menicon Co., Ltd., Seki Plant is registered with the FDA (registration 3002807570) in Seki Gifu, Japan. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 22, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002807570
- Address
- 3, Shinhasama --, Seki Gifu, Japan, 501-3923
- Owner or operator
- MENICON CO. LTD. (9001029)
- Roles
- Manufacturer
- First device listed
- February 23, 2018
- Registered through
- 2026
- Brand names listed
- Miru 1month Menicon (1Month SiHy)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | 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 |
|---|---|---|---|---|---|---|
| February 22, 2018 | K180004 | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens | LPL | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 22, 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.