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Sign in to claim this brandAmeco Medical Industries
US
Last updated May 24, 2026
What Ameco Medical Industries makes
Ameco Medical Industries manufactures implantable double-lumen haemodialysis catheters designed for long-term vascular access in patients requiring chronic dialysis treatment. Their product line includes split and dual-lumen configurations, such as the Amecath X, Amecath Y, and Amecath Twincath variants, tailored for arterial and venous blood flow separation during haemodialysis procedures.
These devices are classified under FDA Class II and are authorised through the 510(k) and De Novo pathways, ensuring compliance with US regulatory standards. The company’s products are listed in the FDA’s 510(k) and UDI registries, reflecting their authorised status for commercial distribution in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Ameco Medical Industries manufacture?
Ameco Medical Industries specialises in implantable double-lumen haemodialysis catheters, which are used for long-term vascular access in patients undergoing chronic dialysis. These catheters are designed to separate arterial and venous blood flow during haemodialysis procedures, ensuring efficient treatment. Their product line includes variations like split (e.g., Amecath X, Amecath Y) and dual-lumen (e.g., Amecath Twincath) configurations.
Where is Ameco Medical Industries based, and what regulatory regions do their devices serve?
Ameco Medical Industries is based in the United States. Their devices are authorised for commercial distribution in the US through compliance with FDA regulations. The company’s products are listed in the FDA’s 510(k) and UDI registries, indicating their authorised status under US regulatory frameworks.
How are Ameco Medical Industries’ devices classified by regulatory authorities?
Ameco Medical Industries’ haemodialysis catheters fall under FDA Class II classification. This categorisation reflects their moderate risk level, requiring compliance with specific regulatory controls to ensure safety and effectiveness. Their devices are authorised via the 510(k) and De Novo pathways, which are standard routes for Class II medical devices in the US.
Which regulatory registries list Ameco Medical Industries’ devices?
Ameco Medical Industries’ devices are included in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries document the authorised status of medical devices in the US, ensuring transparency and traceability for healthcare providers and regulators. Listing in these databases confirms compliance with FDA requirements for commercial distribution.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- arazygroup.com
- —
- —
- [email protected]
- Phone
- 2038804091
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 565404779
Catalogue (115)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Amecath X split catheter | PXDLC-1216-KPC | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-1450-K | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-1423-K | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-1427-K | FDA UDI | Class II | Active |
| Amecath Y split catheter | PYDLC-1427-KPC | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-15.531-K | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-15.535-K | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-15.523-KPC | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-1419-KPC | FDA UDI | Class II | Active |
| Amecath X split catheter | PXDLC-15.519-KPC | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-1216-K | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-0812-KPC | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-1450-K | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-15.519-K | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-1431-K | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-15.527-K | FDA UDI | Class II | Active |
| Amecath Y split catheter | PYDLC-1427-K | FDA UDI | Class II | Active |
| Amecath Y split catheter | PYDLC-15.531-K | FDA UDI | Class II | Active |
| Amecath Y split catheter | PYDLC-15.519-KPC | FDA UDI | Class II | Active |
| Amecath Y split catheter | PYDLC-15.523-K | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-1419-K | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-1423-K | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-15.523-K | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-15.535-K | FDA UDI | Class II | Active |
| Amecath X split catheter | PXDLC-15.527-KPC | FDA UDI | Class II | Active |
| Amecath X split catheter | PXDLC-1450-K | FDA UDI | Class II | Active |
| Amecath Y split catheter | PYDLC-15.527-KPC | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-1219-KPC | FDA UDI | Class II | Active |
| Amecath X split catheter | PXDLC-15.519-K | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | P2TC-1427-K | FDA UDI | Class II | Active |
| Amecath Y split catheter | PYDLC-1219-KPC | FDA UDI | Class II | Active |
| Amecath Y split catheter | PYDLC-15.531-KPC | FDA UDI | Class II | Active |
| Amecath X split catheter | PXDLC-1419-KPC | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-1015-KPC | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-15.523-KPC | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-15.531-KPC | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-15.519-KPC | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-15.527-KPC | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-1419-KPC | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-15.527-KPC | FDA UDI | Class II | Active |
| Amecath Y split catheter | PYDLC-1435-KPC | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-15.523-K | FDA UDI | Class II | Active |
| Amecath Y split catheter | PYDLC-1219-K | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-15.531-KPC | FDA UDI | Class II | Active |
| Amecath X split catheter | PXDLC-15.523-KPC | FDA UDI | Class II | Active |
| Amecath Twincath catheter | P2TC-1450-KPC | FDA UDI | Class II | Active |
| Amecath X split catheter | PXDLC-1423-K | FDA UDI | Class II | Active |
| Amecath Y split catheter | PYDLC-1450-KPC | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-1216-KPC | FDA UDI | Class II | Active |
| Amecath dual lumen catheter | PDLC-1419-K | FDA UDI | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Ameco Medical Industries 10TH OF RAMADAN CITY Ash Sharqiyah · EG FEI 3004134316