Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2084177

FEI Number

2084177

Entity Name

CALATEX, INC.

City/State/Country

Santa Ana, CA, US

Establishment Address

1607 E McFadden Ave Ste H, Santa Ana, CA 92705, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CALATEX, INC. (Owner Number: 9000397)

Owner / Operator Contact Address

1607 E McFadden Ave,, Suite H, Santa Ana, CA 92705, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2015-11-20

Official Correspondent

DUKEE KWON

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CALATEX, INC.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2084177. Last updated year: 2026. Please use registration number 2084177 when referencing this establishment in official correspondence.