Data / Medical devices / Japan / MENICON CO. LTD. Global Logistics Center
MENICON CO. LTD. Global Logistics Center: FDA-registered device maker in Yachiyo Chiba, Japan, 6 510(k) clearances and 1 PMA approval
MENICON CO. LTD. Global Logistics Center is registered with the FDA (registration 3033524682) in Yachiyo Chiba, Japan. It lists 5 device types. The FDA files 6 510(k) clearances and 1 PMA approval under its listings, the newest dated September 17, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033524682
- Address
- 1353-4, Kamikouya, Yachiyo Chiba, Japan, 2760022
- Owner or operator
- MENICON CO. LTD. (9001029)
- Roles
- Remanufacturer, Repackager or relabeler
- First device listed
- November 9, 2007
- Registered through
- 2026
- Brand names listed
- MENICON Z RIGID GAS PERMEABLE CONTACT LENS, Menicon Z DW, Menicon Z Irregular Cornea, Menicon Z Large Diameter, Miru 1day UpSide (1 Day SiHy), Miru 1month Menicon (1Month SiHy)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact (Other Material) - Daily | HQD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lens, Contact (Rigid Gas Permeable), Extended Wear | MWL | 3 | Repackager or relabeler | accessdata.fda.gov |
| Lens, Contact, (Disposable) | MVN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lens, Contact, Orthokeratology, Overnight | NUU | 3 | Repackager or relabeler | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Remanufacturer, Repackager or relabeler | 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 17, 2026 | K262495 | Miru 1day UpSide (midafilcon A) | LPL | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| June 17, 2020 | K193399 | Miru 1day UpSide (midafilcon A) | LPL | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| February 22, 2018 | K180004 | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens | LPL | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| February 3, 2011 | K103561 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| September 23, 2008 | K081443 | MENICON Z RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| October 9, 1996 | K962006 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 11, 2000 | P990018 | MENICON Z RIGID GAS PERMEABLE CONTACT LENS | MWL | 10 | June 16, 2023 | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact, (Disposable)
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact (Other Material) - Daily
- All makers of Lens, Contact, Orthokeratology, Overnight
- All makers of Lens, Contact (Rigid Gas Permeable), Extended Wear
Updated September 17, 2026. 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.