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US
Last updated May 29, 2026
What eemagine Medical Imaging Solutions GmbH makes
The company produces reusable electroencephalographic (EEG) electrode caps, signal amplifiers, and monitoring systems, as well as stereotactic neuronavigation and planning systems for neurosurgical applications. The portfolio includes a range of devices branded under the *waveguard* name, designed for continuous EEG recording and intraoperative monitoring in clinical settings.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable medical device compliance standards for EEG-related and neuronavigation technologies.
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 eemagine Medical Imaging Solutions GmbH manufacture?
eemagine Medical Imaging Solutions GmbH specializes in reusable electroencephalographic (EEG) devices, including electrode caps, signal amplifiers, and monitoring systems. Their portfolio also includes stereotactic neuronavigation and planning systems, which are used for neurosurgical applications. These devices are primarily designed for continuous EEG recording and intraoperative monitoring in clinical environments.
Where is eemagine Medical Imaging Solutions GmbH based?
The company is based in the United States. This location ensures compliance with U.S. medical device regulations, including those governing EEG-related technologies and neuronavigation systems.
Which regulatory registries list eemagine’s devices?
eemagine’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class II medical devices, including EEG monitoring systems and neuronavigation tools, ensuring transparency in the regulatory process.
How are eemagine’s devices classified under FDA regulations?
Under FDA regulations, eemagine’s devices fall under Class II classification. This classification applies to their reusable EEG electrode caps, signal amplifiers, monitoring systems, and stereotactic neuronavigation tools, indicating a moderate level of risk that requires special controls to ensure safety and effectiveness.
What is the primary purpose of eemagine’s *waveguard* branded devices?
The *waveguard* branded devices are designed for continuous EEG recording and intraoperative monitoring. These reusable systems are used in clinical settings to provide real-time brain activity data, supporting diagnostics and surgical planning in neurosurgical applications.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- eemagine.com
- —
- —
- [email protected]
- Phone
- +493029048404
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 313152485
Catalogue (196)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| waveguard | XC-103 | FDA UDI | Class II | Active |
| waveguard | CA-214 | FDA UDI | Class II | Active |
| eego amplifier | EE-430 | FDA UDI | Class II | Active |
| waveguard | CA-203 | FDA UDI | Class II | Active |
| neo | LE-800 | FDA UDI | Class II | Active |
| waveguard | XC-240.EOG | FDA UDI | Class II | Unknown |
| waveguard | CA-212 | FDA UDI | Class II | Active |
| waveguard | XC-135 | FDA UDI | Class II | Active |
| waveguard | XE-293 | FDA UDI | Class II | Active |
| tracking tools | NT-125 | FDA UDI | Class II | Active |
| waveguard | XE-125.2.C | FDA UDI | Class II | Unknown |
| waveguard | CA-104 | FDA UDI | Class II | Active |
| waveguard | XE-292 | FDA UDI | Class II | Active |
| waveguard | CA-191 | FDA UDI | Class II | Active |
| waveguard | CA-421 | FDA UDI | Class II | Active |
| tracking tools | NT-104.0 | FDA UDI | Class II | Active |
| eego amplifier | EE-211 | FDA UDI | Class II | Active |
| waveguard | CA-220 | FDA UDI | Class II | Active |
| waveguard | CA-195 | FDA UDI | Class II | Active |
| waveguard | CS-314 | FDA UDI | Class II | Active |
| waveguard | XE-125.3.A | FDA UDI | Class II | Unknown |
| waveguard | CA-210 | FDA UDI | Class II | Active |
| waveguard | RC-318 | FDA UDI | Class II | Active |
| waveguard | CA-103 | FDA UDI | Class II | Active |
| waveguard | CA-146 | FDA UDI | Class II | Active |
| tracking tools | NT-105 | FDA UDI | Class II | Active |
| waveguard | XE-383 | FDA UDI | Class II | Active |
| waveguard | XE-125.5.A | FDA UDI | Class II | Unknown |
| waveguard | RC-324 | FDA UDI | Class II | Active |
| waveguard | CA-102 | FDA UDI | Class II | Active |
| waveguard | RC-325 | FDA UDI | Class II | Active |
| waveguard | CA-223 | FDA UDI | Class II | Active |
| waveguard | CA-065 | FDA UDI | Class II | Active |
| waveguard | CA-315 | FDA UDI | Class II | Active |
| waveguard | CA-316 | FDA UDI | Class II | Active |
| waveguard | CA-506 | FDA UDI | Class II | Active |
| waveguard | XE-297 | FDA UDI | Class II | Active |
| tracking tools | NT-149 | FDA UDI | Class II | Active |
| waveguard | XE-295 | FDA UDI | Class II | Active |
| waveguard | CA-134 | FDA UDI | Class II | Active |
| waveguard | XE-126 | FDA UDI | Class II | Active |
| tracking tools | NT-123 | FDA UDI | Class II | Active |
| tracking tools | NT-117 | FDA UDI | Class II | Active |
| waveguard | CA-326 | FDA UDI | Class II | Active |
| stimguide | NH-134 | FDA UDI | Class II | Active |
| tracking tools | NT-124 | FDA UDI | Class II | Active |
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