Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007649375

FEI Number

3007649375

Entity Name

M&C Specialties and IVEMSA

City/State/Country

Mexicali Baja California, MX

Establishment Address

Circuito de las Misiones, Sur No. 133 Module 5,, Mexicali Baja California 21600, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

M&C Specialties and IVEMSA (Owner Number: 10029144)

Owner / Operator Contact Address

Cicuito de las Misiones, Sur No. 133 Module 5, Mexicali,, MX-BCN 21600, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EYEMAX PHOTOTHERAPY MASKS EyeMax2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOK	Pad, Neonatal Eye	General Hospital	Class 1	880.5270	2022-03-25
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2009-04-09

Official Correspondent

Oommen Kappil

US Agent Details

Oommen Kappil Business: M&C Specialties Co. Email: okappil@mcspecialties.com Phone: (215) 3221600

Related Public Records

Same Entity

M&C Specialties and IVEMSA

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
1921846	Cardinal Health	Hazelwood, MO, US
3031564213	Posey, S. de R.L. de C.V.	Tijuana Baja California, MX
3005652389	ATOM MEDICAL CORPORATION	Sakura-ku, Saitama-shi, JP
2182318	TIDI PRODUCTS, LLC	NEENAH, WI, US
9612197	Natus Medical Denmark ApS	TAASTRUP Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007649375. Last updated year: 2026. Please use registration number 3007649375 when referencing this establishment in official correspondence.