Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014213264

FEI Number

3014213264

Entity Name

PROEX CORP, S.R.L.

City/State/Country

Ens La Julia Santo Domingo, DO

Establishment Address

Primera No. 4, Edificio Mariposa VI Apartamento No.2, Ens La Julia Santo Domingo 0000, DO

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Proex Corp, S.R.L. (Owner Number: 10056630)

Owner / Operator Contact Address

Primera No. 4, Edificio Mariposa VI Apartamento No.2, Ens La Julia, DO-32 0000, DO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K063005

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
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2026-06-09
FXY	Hood, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-09-26
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-09-26

Official Correspondent

Pedro Valdez Delance

US Agent Details

Celia Parnicky Business: SSPT Inc Email: manager@airshiptrading.com Phone: (954) 2610657

Related Public Records

Same Entity

Proex Corp, S.R.L.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033381	Discus Dental, Inc.	DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL	2004-01-27
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-06	VIASYS Med Systems	2	Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090
Z-0002-06	VIASYS Med Systems	2	Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Stackhouse Mark III Helmet, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090

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3034286426	CIVCO Medical Instruments Co., Inc.	Coralville, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014213264. Last updated year: 2026. Please use registration number 3014213264 when referencing this establishment in official correspondence.