Data / Medical devices / Egypt / Ameco Medical Industries
Ameco Medical Industries: FDA-registered device maker in 10TH OF RAMADAN CITY Ash Sharqiyah, Egypt, 6 510(k) clearances
Ameco Medical Industries is registered with the FDA (registration 3004134316) in 10TH OF RAMADAN CITY Ash Sharqiyah, Egypt. It lists 16 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 5, 2016. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004134316
- Address
- Industrial Area B4 Plot 119 East, 10TH OF RAMADAN CITY Ash Sharqiyah, Egypt, 119
- Owner or operator
- AMECO MEDICAL INDUSTRIES (9072855)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- May 6, 2005
- Registered through
- 2026
- Brand names listed
- AMECATH, AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER, AMECATH INTRODUCTION, AMECATH PERITONEAL CATHETER, AMECATH URETERAL STONE DISLODGER, AMECATH UROLOGICAL CA, AMECO SHEATH INTRODUCER, Amecath Peripheral Inserted Central Venous Catheter Sets and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 5, 2016 | K152819 | Amecath Peripheral inserted Central Venous Catheter Sets | LJS | Substantially Equivalent | Ameco Medical Industries | accessdata.fda.gov |
| August 15, 2013 | K131144 | AMECO SHEATH INTRODUCER | DYB | Substantially Equivalent | Ameco Medical Industries | accessdata.fda.gov |
| July 26, 2013 | K131814 | AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER | MSD | Unknown | Ameco Medical Industries | accessdata.fda.gov |
| April 2, 2013 | K123943 | AMECATH DUAL LUMEN HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | Ameco Medical Industries | accessdata.fda.gov |
| December 21, 2011 | K110794 | AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS | FOZ | Substantially Equivalent | Ameco Medical Industries | accessdata.fda.gov |
| December 16, 2011 | K110793 | AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS | MPB | Substantially Equivalent | Ameco Medical Industries | accessdata.fda.gov |
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Updated February 5, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.