Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003779166

FEI Number

3003779166

Entity Name

MENICON PHARMA SAS

City/State/Country

ILLKIRCH-GRAFFENSTADEN Bas-Rhin, FR

Establishment Address

BLD SEBASTIEN BRANT, PARC D INNOVATION, ILLKIRCH-GRAFFENSTADEN Bas-Rhin 67400, FR

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

K130805

PMA Number

N/A

All Registered Proprietary Names

Menicon Unique pH Multi-Purpose Solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	Class 2	886.5918	2013-07-07

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 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

Similar Registrations

Registration Number	Establishment Name	Location
3003515967	MENICON AMERICA, INC.	North Billerica, MA, US
3003306559	GLOBAL PACKAGING SYSTEMS INC	Fort Worth, TX, US
1032500	Bausch & Lomb Incorporated	GREENVILLE, SC, US
3003093882	NIAGARA PHARMACEUTICALS, INC.	Dundas Ontario, CA
1313525	Bausch & Lomb Incorporated	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003779166. Last updated year: 2026. Please use registration number 3003779166 when referencing this establishment in official correspondence.