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Sign in to claim this brandAvante
US
Last updated May 24, 2026
What Avante makes
Avante manufactures bedside and operating room medical devices, including multi-parameter patient monitors, ECG systems, and reusable blood pressure cuffs. Their portfolio also includes pulse oximeters, transcutaneous blood gas monitoring modules, and general-purpose ultrasound imaging systems, as well as specialized lighting solutions for medical environments. Additional offerings include line-powered oximeters and nasal CO₂ sampling cannulas with oxygen delivery.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are designed for clinical use in the United States, adhering to regulatory requirements for medical monitoring and imaging equipment.
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 Avante manufacture?
Avante specializes in bedside and operating room medical devices. Their portfolio includes multi-parameter patient monitors, ECG systems, reusable blood pressure cuffs, pulse oximeters, transcutaneous blood gas monitoring modules, general-purpose ultrasound imaging systems, and specialized medical lighting solutions like LED systems. These devices are designed for clinical monitoring and procedural environments, ensuring compatibility with various healthcare settings.
Where is Avante based, and what does that mean for its regulatory compliance?
Avante is based in the United States, which means its devices are developed and marketed in compliance with FDA regulations. Since the company’s products fall under FDA’s Class I and Class II categories, they must meet specific requirements for safety, performance, and labeling as outlined by the FDA. Their devices are also listed in the FDA’s Unique Device Identifier (UDI) database, which helps ensure traceability and regulatory transparency.
Which regulatory registries list Avante’s medical devices?
Avante’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices throughout their distribution and helps ensure regulatory compliance and traceability. This listing is essential for healthcare providers, regulators, and other stakeholders to verify device details and compliance status.
How are Avante’s medical devices classified under FDA regulations?
Avante’s devices are classified under two main FDA categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, ensuring appropriate regulatory oversight.
What kinds of devices does Avante offer for patient monitoring and diagnostic imaging?
Avante provides a range of patient monitoring and diagnostic imaging solutions, including general-purpose bedside monitors that track multiple vital signs, ECG systems for professional multichannel cardiac monitoring, and reusable blood pressure cuffs for consistent measurements. Additionally, their portfolio includes general-purpose ultrasound imaging systems for diagnostic imaging and transcutaneous blood gas monitoring modules for assessing oxygen and carbon dioxide levels in patients. These devices are designed to support clinical decision-making in various healthcare settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dremed.com
- —
- —
- [email protected]
- Phone
- 502-244-4444
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 178440426
Catalogue (259)
Page 1 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Savoy QA3 | 7QA3MXP | FDA UDI | Class II | Active |
| Waveline Nano B2 | 60139 | FDA UDI | Class II | Active |
| True ECG Plus | 60135I | FDA UDI | Class II | Active |
| E-St | 60132 | FDA UDI | Class II | Active |
| Vision Ex5 | DRE 061424 | FDA UDI | Class II | Active |
| Premio E250 | 7JVIP2 | FDA UDI | Class II | Active |
| Maxx Luxx Led | AHS SD2 | FDA UDI | Class II | Active |
| Blood Pressure Cuff | 80031LAXL | FDA UDI | Class II | Active |
| Nasal CO2 Sampling Cannula With O2 Delivery | P04092D | FDA UDI | Class II | Active |
| E-ST Pro | 60132PRO8 | FDA UDI | Class II | Active |
| Vision Led | DRE 061523B-V | FDA UDI | Class II | Active |
| Blood Pressure Cuff | 80031ID | FDA UDI | Class II | Active |
| True ECG Advance | 60137 | FDA UDI | Class II | Active |
| Blood Pressure Cuff | 80031DC | FDA UDI | Class II | Active |
| Waveline EZ+ | 60144CO2 | FDA UDI | Class II | Active |
| Blood Pressure Cuff | 80031ABL | FDA UDI | Class II | Active |
| Vision Ex5 | DRE 061425-V | FDA UDI | Class II | Active |
| Crystal 4P | 60138U50E | FDA UDI | Class II | Active |
| Waveline Pro+ | 60146TESP | FDA UDI | Class II | Active |
| FS-60 Advance | 60138N | FDA UDI | Class II | Active |
| Vista LED | DRE 061314 | FDA UDI | Class I | Active |
| Maxx Luxx Led | AHS SD2SD2P3M1 | FDA UDI | Class II | Active |
| Millennium 5 | 7JE200EXT | FDA UDI | Class II | Active |
| Vista LED | DRE 061322-V | FDA UDI | Class I | Active |
| Premio E250 | 7JVIPRS | FDA UDI | Class II | Active |
| Echo CO2 | 60129MC | FDA UDI | Class II | Active |
| Millennium 5 | 7JE200 | FDA UDI | Class II | Active |
| Maxx Luxx Led | AHS SD2D2P3-V | FDA UDI | Class II | Active |
| Maxx Luxx Led | AHS SD2P3 | FDA UDI | Class II | Active |
| Waveline Pro+ | 60146TC | FDA UDI | Class II | Active |
| Maxx Luxx Led | AHS SD2D2P4-V | FDA UDI | Class II | Active |
| Compact Plus | 60131I | FDA UDI | Class II | Active |
| Vision Ex5 | DRE 061423B | FDA UDI | Class II | Active |
| Blood Pressure Cuff | 80031SA | FDA UDI | Class II | Active |
| E-St | 60132PRO2 | FDA UDI | Class II | Active |
| Maxx Luxx Led | AHS SD2VR-V | FDA UDI | Class II | Active |
| Waveline Pro+ | 60146TCB | FDA UDI | Class II | Active |
| Vision Led | DRE 061522-V | FDA UDI | Class II | Active |
| Blood Pressure Cuff | 80031DT | FDA UDI | Class II | Active |
| Dm-530 | 70180P | FDA UDI | Class II | Active |
| Maxx Luxx Led | AHS SD2M1-V | FDA UDI | Class II | Active |
| Sls 9000 | 70Z500WM | FDA UDI | Class II | Active |
| Vista LED | DRE 061325-V | FDA UDI | Class I | Active |
| 6000 Anesthesia Replacement Oxygen Cell | R109P45-003 | FDA UDI | Class II | Active |
| Vision Ex5 | DRE 061412-V | FDA UDI | Class II | Active |
| Sage 12c | 60130H | FDA UDI | Class II | Active |
| Waveline Pro+ | 60146NEST | FDA UDI | Class II | Active |
| Vision Led | DRE 061523B | FDA UDI | Class II | Active |
| Echo | 60129R | FDA UDI | Class II | Active |
| E-St | 601323 | FDA UDI | Class II | Active |
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