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Sign in to claim this brandEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
US
Last updated May 23, 2026
What EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED makes
EPIC International manufactures elastomeric infusion pump systems designed for continuous, controlled fluid delivery, as well as intravenous administration bags and bottles for medication or fluid storage. Their portfolio includes vial and bottle adaptors, Luer connectors, non-standard bag access spikes, fluid transfer sets, intravenous tubing extensions, and catheter injection ports, all intended for single-use in clinical settings. The company also produces hermetically sealed connectors and closed-system transfer devices to enhance safety during fluid administration.
The company’s devices are classified under FDA’s Class I and Class II categories, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in the United States, adhering to regulatory requirements for medical devices in that jurisdiction. The manufacturer is based in the US, ensuring compliance with domestic and international standards for infusion and fluid management systems.
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 EPIC International manufacture?
EPIC International specializes in devices for fluid administration and infusion therapy. Their portfolio includes elastomeric infusion pump systems for continuous, controlled fluid delivery, intravenous administration bags and bottles for medication or fluids, and accessories like vial/bottle adaptors, Luer connectors, bag access spikes, fluid transfer sets, tubing extensions, and catheter injection ports. These products are designed for single-use in clinical settings to ensure patient safety and regulatory compliance.
Where is EPIC International based, and what does that mean for their devices?
EPIC International is based in the United States, which means their devices are developed and manufactured under US regulatory standards. This ensures compliance with FDA requirements for medical devices, including classification, labeling, and post-market surveillance. The US location also facilitates adherence to both domestic and international quality and safety guidelines for infusion and fluid management systems.
Which regulatory registries list EPIC International’s devices?
EPIC International’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory compliance and post-market monitoring. Listing in this database is required for Class I and Class II devices, which aligns with the company’s product portfolio.
How are EPIC International’s devices classified under FDA regulations?
EPIC International’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and the body part it interacts with, as outlined in FDA’s regulatory framework.
What does it mean for EPIC International’s devices to be listed in the FDA UDI database?
Listing in the FDA UDI database means each of EPIC International’s devices has a unique identifier that includes a device identifier and a production identifier. This system improves device tracking, reduces medical errors, and supports regulatory oversight by providing clear, standardized information about the device’s manufacturer, model, batch, and expiration. It also aids healthcare providers in verifying product authenticity and compliance with FDA requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 662213220
Catalogue (128)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SimplFusor | 480052BAX | FDA UDI | Class II | Active |
| SMARTeZ Pump | 481132 | FDA UDI | Class II | Active |
| eZSURE™ | 426170 | EUDAMEDFDA UDI | Class II | Active |
| SMARTeZ Pump | 481122 | FDA UDI | Class II | Active |
| SimplFusor | 480182BAX | FDA UDI | Class II | Active |
| eZSURE™ | 426030 | EUDAMEDFDA UDI | Class II | Active |
| eZSURE™ | 426110 | EUDAMEDFDA UDI | Class II | Active |
| SMARTeZ Pump | 481152 | FDA UDI | Class II | Active |
| Dosi-Fuser | L25915-100D2-USA | FDA UDI | Class II | Active |
| SMARTeZ Pump | 480191 | EUDAMEDFDA UDI | Class II | Active |
| SMARTeZ Pump | 480011 | EUDAMEDFDA UDI | Class II | Active |
| ProSeal CSTD | 421010VT | EUDAMEDFDA UDI | Class II | Active |
| SimplFusor | 481093BAX | FDA UDI | Class II | Active |
| SMARTeZ Pump | 481052 | FDA UDI | Class II | Active |
| SMARTeZ Pump | 481042 | FDA UDI | Class II | Active |
| SMARTeZ Pump | 481012 | FDA UDI | Class II | Active |
| SimplFusor | 480062BAX | FDA UDI | Class II | Active |
| eZSURE™ | 426140 | EUDAMEDFDA UDI | Class II | Active |
| SimplFusor | 480082BAX | FDA UDI | Class II | Active |
| SimplFusor | 484252BAX | FDA UDI | Class II | Active |
| SMARTeZ Pump | 481081 | EUDAMEDFDA UDI | Class II | Active |
| SMARTeZ Pump | 480131 | EUDAMEDFDA UDI | Class II | Active |
| eZSURE™ | 426040 | EUDAMEDFDA UDI | Class II | Active |
| SMARTeZ Fluid Transfer Set | 470020 | FDA UDI | Class I | Active |
| ProSeal CSTD | 420690 | FDA UDI | Class II | Active |
| SimplFusor | 480132BAX | FDA UDI | Class II | Active |
| SMARTeZ Pump | 481092 | FDA UDI | Class II | Active |
| SMARTeZ Pump | 480081 | EUDAMEDFDA UDI | Class II | Active |
| SimplFusor | 481066BAX | FDA UDI | Class II | Active |
| SimplFusor | 484012BAX | FDA UDI | Class II | Active |
| Dosi-Fuser | L25915-250D2-USA | FDA UDI | Class II | Active |
| SimplFusor | 480072BAX | FDA UDI | Class II | Active |
| SimplFusor | 481043BAX | FDA UDI | Class II | Active |
| SimplFusor | 481102BAX | FDA UDI | Class II | Active |
| Dosi-Fuser | L25915-250D7-USA | FDA UDI | Class II | Active |
| ProSeal CSTD | 423850VT | EUDAMEDFDA UDI | Class II | Active |
| SimplFusor | 480612BAX | FDA UDI | Class II | Active |
| ProSeal CSTD | 420700 | FDA UDI | Class II | Active |
| SMARTeZ Pump | 481066 | FDA UDI | Class II | Active |
| eZSURE™ | 426060 | EUDAMEDFDA UDI | Class II | Active |
| Dosi-Fuser | L25915-065D5-USA | FDA UDI | Class II | Active |
| SMARTeZ Pump | 481046 | FDA UDI | Class II | Active |
| SimplFusor | 480092BAX | FDA UDI | Class II | Active |
| SimplFusor | 481122BAX | FDA UDI | Class II | Active |
| SMARTeZ Pump | 484011 | EUDAMEDFDA UDI | Class II | Active |
| Dosi-Fuser | L25915-250D1-USA | FDA UDI | Class II | Active |
| SimplFusor | 481142BAX | FDA UDI | Class II | Active |
| SMARTeZ Pump | 480141 | EUDAMEDFDA UDI | Class II | Active |
| SMARTeZ Pump KVO | 498111 | EUDAMEDFDA UDI | Class II | Active |
| SMARTeZ Pump | 480111 | EUDAMEDFDA UDI | Class II | Active |
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