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Data / Medical devices / Singapore / Menicon Singapore Pte. Ltd. (Site 2)

Menicon Singapore Pte. Ltd. (Site 2): FDA-registered device maker in SINGAPORE South West, Singapore, 1 510(k) clearance

Menicon Singapore Pte. Ltd. (Site 2) is registered with the FDA (registration 3011861185) in SINGAPORE South West, Singapore. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 28, 2011. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number
3011861185
Address
2 Tukang Innovation Grove #01-04 JTC Medtech Hub, SINGAPORE South West, Singapore, 618305
Owner or operator
MENICON CO. LTD. (9001029)
Roles
Manufacturer
First device listed
May 8, 2011
Registered through
2026
Brand names listed
Miru 1day Menicon Flat Pack, Miru 1day Menicon Flat Pack Toric

Devices it lists

DeviceProduct codeClassRoleSource
Lenses, Soft Contact, Daily WearLPL2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 28, 2011K102895ONE DAY FLAT PACKLPLSubstantially EquivalentMenicon Co, Ltd.accessdata.fda.gov

Compare with other makers

Updated April 28, 2011. 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.