QEL DOMINICANA S.A.

FDA Device Registration & Listing · ESPERANZA Valverde, DO · Registration 3005360866

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005360866
FEI Number
3005360866
Entity Name
QEL DOMINICANA S.A.
City/State/Country
ESPERANZA Valverde, DO
Establishment Address
ZONA FRANCA ESPERANZA, ESPERANZA Valverde --, DO
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
QEL DOMINICANA S.A. (Owner Number: 9077771)
Owner / Operator Contact Address
ZONA FRANCA ESPERANZA, --, ESPERANZA, DO-NOTA --, DO
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

QMD MEDICAL QMD MEDICAL disposible patient gown and accessory

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FQM Bandage, Elastic General Hospital Class 1 880.5075 2005-09-20
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2005-09-20
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2014-03-18

Official Correspondent

No official correspondent registered.

US Agent Details

Jeff Ayoub Business: GMK Email: jayoub@calkogroup.com Phone: (800) 3611190

Related Public Records

Same Entity

QEL DOMINICANA 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 3005360866. Last updated year: 2026. Please use registration number 3005360866 when referencing this establishment in official correspondence.
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