Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010607087

FEI Number

3010607087

Entity Name

Menicon Nect Co., Ltd., Gujo Plant

City/State/Country

Gujo Gifu, JP

Establishment Address

15, Shimizumoto, Hachimancho-Asahi, Gujo Gifu 501-4204, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MENICON CO. LTD. (Owner Number: 9001029)

Owner / Operator Contact Address

21-19 AOI, 3-CHOME, NAKA-KU, --, NAGOYA, JP-23 460-0006, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P990018

All Registered Proprietary Names

Menicon Z Irregular Cornea Menicon Z Large Diameter MeniSept LacriPure MENICON Z RIGID GAS PERMEABLE CONTACT LENS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2008-10-31
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2011-08-30
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	Class 2	886.5918	2021-07-14
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2021-07-14
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2016-01-15
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	Class 2	886.5918	2016-01-15
NUU	Lens, Contact, Orthokeratology, Overnight	Ophthalmic	Class 3	886.5916	2007-11-09
MWL	Lens, Contact (Rigid Gas Permeable), Extended Wear	Ophthalmic	Class 3	886.5916	2007-11-09

Official Correspondent

Zhu Jiang

US Agent Details

Alberty Recio Business: MENICON AMERICA, INC. Email: alberty_recio@menicon.com Phone: (781) 6092042

Related Public Records

Same Entity

MENICON CO. LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011861185	Menicon Singapore Pte. Ltd. (Site 2)	SINGAPORE South West, SG
3010413909	Menicon Nect Co., Ltd.	Nagoya Aichi, JP
3002807570	Menicon Co., Ltd., Seki Plant	Seki Gifu, JP
3014768085	Menicon Co., Ltd., Kakamigahara Plant	Kakamigahara Gifu, JP
3009104180	Menicon Singapore Pte. Ltd.	Singapore South West, SG

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K963512	Benz Research and Development Corp.	BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL	1997-07-31
K093254	Abbott Medical Optics, Inc.	AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION	2010-09-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2022	Contamac Solutions, Inc.	2	Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
Z-0028-05	Ciba Vision Corporation	2	SOLO-care Plus with Aqualube, Multi-purpose solution* AquaSoft (Private label), Multi-purpose solutionSterile**For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.
Z-0129-2011	Abbott Medical Optics Inc (AMO)	2	AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
Z-0130-2011	Abbott Medical Optics Inc (AMO)	2	AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.

Similar Registrations

Registration Number	Establishment Name	Location
3032010300	TIANJIN MASTERVISION TECHNOLOGY CO., LTD.	Wuqing District Tianjin, CN
3005994941	SOLOTICA INDUSTRIA E COMERCIO LTDA	Sao Paulo, BR
1835957	ART OPTICAL CONTACT LENS, INC.	Walker, MI, US
3025308027	BIOLENS LAB	Mohammedia Mohammadia, MA
1065845	X-CEL SPECIALTY CONTACTS	DULUTH, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010607087. Last updated year: 2026. Please use registration number 3010607087 when referencing this establishment in official correspondence.