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Sign in to claim this brandActa Medical LLC
US
Last updated May 24, 2026
What Acta Medical LLC makes
Acta Medical LLC manufactures intravenous administration bags and noninvasive basic intravenous administration sets. These products are designed for the controlled delivery of fluids and medications directly into a patient’s bloodstream, ensuring compatibility with standard hospital and clinical workflows.
The company’s devices are classified as Class II under FDA regulations and are authorised through 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. The products are listed in the FDA’s regulatory databases, adhering to U.S. medical device compliance standards.
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 Acta Medical LLC manufacture?
Acta Medical LLC specializes in intravenous administration devices, specifically intravenous administration bags and noninvasive basic intravenous administration sets. These products are engineered to deliver fluids and medications safely and efficiently into a patient’s bloodstream, aligning with common clinical practices in hospitals and medical facilities.
Where is Acta Medical LLC based?
Acta Medical LLC is based in the United States. The company’s location ensures compliance with U.S. regulatory standards for medical devices, including those governed by the FDA.
Which regulatory registries or databases list Acta Medical LLC’s devices?
Acta Medical LLC’s devices are listed in the FDA’s regulatory databases, including the 510(k) clearance registry and the Unique Device Identification (UDI) system. These registries track authorised medical devices under U.S. regulations, ensuring transparency and compliance.
How are Acta Medical LLC’s devices classified under FDA regulations?
Acta Medical LLC’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as intravenous administration sets and bags.
Why are Acta Medical LLC’s devices authorised through the FDA’s 510(k) process?
The FDA’s 510(k) clearance process is used for Class II devices to demonstrate that the product is substantially equivalent to a legally marketed predicate device. Since Acta Medical LLC’s devices are designed for intravenous administration—a well-established category—this pathway ensures they meet performance and safety standards without requiring the higher scrutiny of a Class III premarket approval.
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
- 117299766
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acta Medical | AMA0250 | FDA UDI | Class II | Active |
| Acta Medical | ACTAPPS003W | FDA UDI | Class II | Active |
| Acta Medical | ACTAPPS-TRI | FDA UDI | Class II | Active |
| Acta Medical | AMA0150HS | FDA UDI | Class II | Active |
| Acta Medical | ACTAPPS003WC | FDA UDI | Class II | Unknown |
| Acta Medical | AMA0105 | FDA UDI | Class II | Active |
| Acta Medical | ACTAMIX1000 | FDA UDI | Class II | Active |
| Acta Medical | ACTAPST001 | FDA UDI | Class II | Active |
| Right Way Medical | RWM-10002 | FDA UDI | Class II | Active |
| DJF Med | DJF500J | FDA UDI | Class II | Active |
| DJF Med | DJF1000FS | FDA UDI | Class II | Active |
| Acta Medical | ACTA2P0500 | FDA UDI | Class II | Active |
| Acta Medical | AMA0500V | FDA UDI | Class II | Active |
| Acta Medical | ACTA2P0100 | FDA UDI | Class II | Active |
| Acta Medical | AMBFL003 | FDA UDI | Class II | Active |
| Acta Medical | AL72023E | FDA UDI | Class II | Active |
| Acta Medical | AMA0500 | FDA UDI | Class II | Active |
| Acta Medical | AMBFL0013 | FDA UDI | Class II | Active |
| Acta Medical | ACTAMIX0250 | FDA UDI | Class II | Active |
| Acta Medical | AMA0250V | FDA UDI | Class II | Active |
| Acta Medical | AMBFL001 | FDA UDI | Class II | Active |
| Acta Medical | ACTAVBA003 | FDA UDI | Class II | Active |
| Acta Medical | ACTAPST003W | FDA UDI | Class II | Active |
| Acta Medical | AMFR001 | FDA UDI | Class II | Active |
| Acta Medical | ACTAVBA001 | FDA UDI | Class II | Active |
| Caretech | 286022EA | FDA UDI | Class II | Active |
| Acta Medical | AMBFL004 | FDA UDI | Class II | Active |
| Acta Medical | ACTAPPS001 | FDA UDI | Class II | Active |
| Acta Medical | M3000-1 | FDA UDI | Class II | Active |
| Acta Medical | ACTA2P0250 | FDA UDI | Class II | Active |
| Acta Medical | ACTAPPS003 | FDA UDI | Class II | Active |
| DJF Med | DJF1000F | FDA UDI | Class II | Active |
| Right Way Medical | RWM-5002 | FDA UDI | Class II | Active |
| Acta Medical | ACTAMIX3000 | FDA UDI | Class II | Active |
| Acta Medical | ACTAVBA004 | FDA UDI | Class II | Active |
| Acta Medical | ACTAMIX0500 | FDA UDI | Class II | Active |
| Acta Medical | ACTAMIX4000 | FDA UDI | Class II | Active |
| Acta Medical | ACTAMIX2000 | FDA UDI | Class II | Active |
| Acta Medical | AMA0150HSV | FDA UDI | Class II | Active |
| DJF Med | DJF1000J | FDA UDI | Class II | Active |
| Enteral Administration Set With Solution Container, Enteral Administration Set, Enteral Extension Set With Minitube Conn | K112863 | FDA 510(k) | Class II | Active |
| Empty Eva Solution Container Empty Eva Dual Chamber Solution Container | K121161 | FDA 510(k) | Class II | Active |
| Intravascular Administration Set | K121803 | FDA 510(k) | Class II | Active |
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