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Sign in to claim this brandAccumedx, LLC
US
Last updated May 24, 2026
What Accumedx, LLC makes
Accumedx, LLC manufactures single-use laparoscopic and endoscopic devices, including access cannulas for minimally invasive surgery, monopolar electrosurgical electrodes and handpieces, spring-loaded pneumoperitoneum needles, and tissue extraction bags. Their products are designed for use in surgical procedures requiring precise irrigation, electrosurgical control, and safe tissue retrieval. The company also supplies endoscopic irrigation tubing sets for fluid management during procedures.
All of Accumedx’s products fall under Class II regulatory classification in the US, with each device listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States, adhering to domestic regulatory requirements for medical devices.
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 Accumedx, LLC manufacture?
Accumedx, LLC specializes in single-use laparoscopic and endoscopic devices. Their product line includes laparoscopic access cannulas for minimally invasive surgery, monopolar electrosurgical electrodes and handpieces for tissue coagulation, spring-loaded pneumoperitoneum needles for insufflation, tissue extraction bags for safe specimen retrieval, and endoscopic irrigation tubing sets for fluid management during procedures. These devices are designed to support precise surgical control and fluid management in minimally invasive procedures.
Where is Accumedx, LLC based, and what regulatory framework does it follow?
Accumedx, LLC is based in the United States. Since their devices are manufactured domestically, they must comply with the US regulatory requirements for medical devices, including registration, listing, and adherence to applicable standards for their specific product categories. The company’s devices are subject to the regulatory oversight of the FDA, which classifies them under Class II due to their intended use and associated risks.
Are Accumedx’s devices listed in any regulatory registries, and why does this matter?
Yes, all of Accumedx’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to quickly identify and verify the specific device model, batch, and manufacturer details. Listing in the UDI database is a requirement for Class II devices in the US, helping to streamline post-market surveillance and recall processes.
How are Accumedx’s devices classified under US regulations, and what does this classification imply?
Accumedx’s devices are classified as Class II under US regulations. This classification is based on their intended use and the level of risk they pose to patients. Class II devices generally require special controls beyond general controls (like good manufacturing practices) to ensure their safety and effectiveness. These controls may include performance standards, post-market surveillance, or labeling requirements, ensuring that the devices meet specific regulatory expectations before they enter the market.
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
- 096236324
Catalogue (29)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AccuMedx | AMMUG-33 | FDA UDI | Class II | Active |
| AccuMedx | AM12-150 | FDA UDI | Class II | Active |
| AccuMedx | AMSI-45 | FDA UDI | Class II | Active |
| AccuMedx | AMMGP-33 | FDA UDI | Class II | Active |
| AccuMedx | AMMDM-33 | FDA UDI | Class II | Active |
| AccuMedx | AMO12-150 | FDA UDI | Class II | Active |
| AccuMedx | AMSR10-400 | FDA UDI | Class II | Active |
| AccuMedx | AMO15-100 | FDA UDI | Class II | Active |
| AccuMedx | AMMCH-33 | FDA UDI | Class II | Active |
| AccuMedx | AM5-100 | FDA UDI | Class II | Active |
| AccuMedx | AMSI-45S | FDA UDI | Class II | Active |
| AccuMedx | AMMSS-33 | FDA UDI | N/A | Active |
| AccuMedx | AMVN-120 | FDA UDI | Class II | Active |
| AccuMedx | AMMSC-33 | FDA UDI | Class II | Active |
| AccuMedx | AMMAI-33 | FDA UDI | Class II | Active |
| AccuMedx | AM15-150 | FDA UDI | Class II | Active |
| AccuMedx | AMMBK-33 | FDA UDI | Class II | Active |
| AccuMedx | AMMDS-33 | FDA UDI | N/A | Active |
| AccuMedx | AM5-150 | FDA UDI | Class II | Active |
| AccuMedx | AMSI-33 | FDA UDI | Class II | Active |
| AccuMedx | AMO5-100 | FDA UDI | Class II | Active |
| AccuMedx | AM15-100 | FDA UDI | Class II | Active |
| AccuMedx | AMVN-150 | FDA UDI | Class II | Active |
| AccuMedx | AM12-100 | FDA UDI | Class II | Active |
| AccuMedx | AMSI-33S | FDA UDI | Class II | Active |
| AccuMedx | AMO5-150 | FDA UDI | Class II | Active |
| AccuMedx | AMO15-150 | FDA UDI | Class II | Active |
| AccuMedx | AMO12-100 | FDA UDI | Class II | Active |
| AccuMedx | AMSR10-200 | FDA UDI | Class II | Active |
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