Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009754517

FEI Number

3009754517

Entity Name

ZAIMELLA DEL ECUADOR S A

City/State/Country

QUITO Pichincha, EC

Establishment Address

Jacinto Jijon y Caamano, Juan de Dios Morales, Sector La Balbina, QUITO Pichincha 17079667, EC

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zaimella del Ecuador S.A. (Owner Number: 10041603)

Owner / Operator Contact Address

Calle Juan de Dios Morales Lote #1 y, Panamericana Sur, Sector La Balbina, QUITO, EC-P 17079667, EC

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ZAIMELLA DEL ECUADOR S A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2012-08-10

Official Correspondent

No official correspondent registered.

US Agent Details

GIAN CARLO DI MELLA Business: Zaimella Email: notificacioneslegales@zaimella.com Phone: (305) 7137144

Related Public Records

Same Entity

Zaimella del Ecuador S.A.

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 3009754517. Last updated year: 2026. Please use registration number 3009754517 when referencing this establishment in official correspondence.