Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004134316

FEI Number

3004134316

Entity Name

AMECO MEDICAL INDUSTRIES

City/State/Country

10TH OF RAMADAN CITY Ash Sharqiyah, EG

Establishment Address

INDUSTRIAL AREA B4, PLOT 119 EAST, 10TH OF RAMADAN CITY Ash Sharqiyah 119, EG

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

AMECO MEDICAL INDUSTRIES (Owner Number: 9072855)

Owner / Operator Contact Address

Industrial Area B4 - Plot 119 East, 10th of Ramadan 119, EG-NOTA 119, EG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AMECATH UROLOGICAL CA AMECATH UROLOGICAL CA Amecath Peripheral Inserted Central Venous Catheter Sets AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER Amecath Urodynamic Lumen Catheter AMECATH INTRODUCTION DRAINAGE CATHETER AND ACCESSORIES Hemodialysis Non-implanted Catheter DRAINAGE CATHETER AND ACCESSORIES AMECATH INTRODUCTION Catheter,intravascular,therapeutic, AMECO SHEATH INTRODUCER AMECATH INTRODUCTION DRAINAGE CATHETER AND ACCESSORIES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EYK	Connector, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2005-05-06
EYA	Stylet, Ureteral	Gastroenterology, Urology	Class 1	876.5130	2005-05-06
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2018-01-14
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-12-24
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2010-05-14
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2005-05-06
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2012-02-12
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2005-05-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2012-02-12
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-12-24
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2005-05-06

Official Correspondent

Ahmed Moustafa

US Agent Details

Benzy Arazy Business: Medes USA C/O Matan Arazy Email: Medes@Arazygroup.com Phone: (415) 9921126

Related Public Records

Same Entity

AMECO MEDICAL INDUSTRIES

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
K971999	B.Braun Medical, Inc.	PERIPHERALLY INSERTED CENTRAL	1997-11-24
K171618	Medcomp (Dba Medical Components, Inc.)	Symetrex Long Term Hemodialysis Catheter	2017-11-16
K111817	Covidien	PALINDROME RT CHRONIC CATHETER	2011-08-30
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Z-0004-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0025-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
Z-0026-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.
Z-0027-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004134316. Last updated year: 2026. Please use registration number 3004134316 when referencing this establishment in official correspondence.