Data / Medical devices / Netherlands / Menicon B.V.

Menicon B.V.: FDA-registered device maker in Emmen Drenthe, Netherlands, 8 510(k) clearances and 1 PMA approval

Name: Menicon B.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Menicon B.V. is registered with the FDA (registration 3003357577) in Emmen Drenthe, Netherlands. It lists 3 device types. The FDA files 8 510(k) clearances and 1 PMA approval under its listings, the newest dated April 25, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003357577
Address: Waanderweg 6, Emmen Drenthe, Netherlands, 7812 HZ
Owner or operator: MENICON CO. LTD. (9001029)
Roles: Manufacturer
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

Devices it lists

Device	Product code	Class	Role	Source
Lens, Contact (Other Material) - Daily	HQD	2	Manufacturer	accessdata.fda.gov
Lens, Contact (Rigid Gas Permeable), Extended Wear	MWL	3	Manufacturer	accessdata.fda.gov
Lens, Contact, Orthokeratology, Overnight	NUU	3	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 25, 2018	K180616	OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens	HQD	Substantially Equivalent	Contamac, Ltd.	accessdata.fda.gov
August 10, 2016	K161100	Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses	HQD	Substantially Equivalent	Contamac, 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
May 1, 2007	K070628	OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.	HQD	Substantially Equivalent	Contamac, Ltd.	accessdata.fda.gov
November 1, 2006	K062548	MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES	HQD	Substantially Equivalent	Contamac, Ltd.	accessdata.fda.gov
March 19, 2004	K033594	OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES	HQD	Substantially Equivalent	Contamac, 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

Updated June 16, 2023. 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.