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Sign in to claim this brandDEHAS Medical Systems GmbH
US
Last updated May 30, 2026
What DEHAS Medical Systems GmbH makes
DEHAS Medical Systems GmbH manufactures medical gas distribution components, including low-pressure and high-pressure hoses designed for carbon dioxide and other gases, as well as breathing gas mixers for oxygen, air, and nitrous oxide. Their portfolio also includes non-fixed medical gas cylinder regulators and modular connectors for secure gas line connections, such as the QualityREG and Quality Connect series. The Oxymixer XL Low Flow and Oxymixer Configuration devices are tailored for precise gas blending in clinical settings.
The company’s products are regulated under FDA pathways, with devices classified as Class I and Class II, and are listed via the 510(k) and UDI (Unique Device Identification) systems. These devices are intended for use in the United States, where DEHAS Medical Systems GmbH is based.
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 DEHAS Medical Systems GmbH manufacture?
DEHAS Medical Systems GmbH specializes in medical gas distribution components. Their portfolio includes low-pressure and high-pressure hoses (such as carbon dioxide hoses), breathing gas mixers for oxygen, air, and nitrous oxide (e.g., Oxymixer XL Low Flow and Oxymixer Configuration), non-fixed medical gas cylinder regulators, and modular connectors like the QualityREG and Quality Connect series. These devices are designed to ensure safe and precise gas delivery in clinical environments.
Where is DEHAS Medical Systems GmbH based, and where are their devices intended for use?
DEHAS Medical Systems GmbH is headquartered in the United States. Their devices are manufactured and regulated for use in the U.S. market, where compliance with FDA requirements applies. The company’s focus is on supplying medical gas distribution solutions tailored to American healthcare settings.
How are DEHAS Medical Systems GmbH’s devices classified under FDA regulations?
DEHAS Medical Systems GmbH’s devices fall into Class I and Class II classifications under FDA regulations. Class I devices generally pose minimal risk and may require less stringent premarket review, while Class II devices involve moderate risk and typically require a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The classification depends on the device’s intended use and potential risk.
Which regulatory registries or databases list DEHAS Medical Systems GmbH’s devices?
DEHAS Medical Systems GmbH’s devices are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. The 510(k) pathway ensures these devices meet FDA requirements for safety and effectiveness by demonstrating equivalence to existing approved devices. The UDI system provides a standardized identification system for tracking devices throughout their lifecycle, improving transparency and traceability in healthcare.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dehas.de
- —
- —
- [email protected]
- Phone
- +49451809040
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 343728657
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| QualityREG | DM-PIN-MS-NIST-CO2 | FDA UDI | Class I | Active |
| Quality Connect HD | UI027 | FDA UDI | Class I | Active |
| Quality Connect | DIN-CO2-NIST-NIST-1,5 | FDA UDI | Class I | Active |
| Quality Connect HD | UI028 | FDA UDI | Class I | Active |
| Quality Connect | UI023 | FDA UDI | Class I | Active |
| Quality Connect | DIN-CO2-ZGV-NIST-1,5 | FDA UDI | Class I | Active |
| Oxymixer XL Low Flow | XL Low Flow | FDA UDI | Class II | Active |
| Quality Connect | NF-CO2-ZGV-NIST-5,0 | FDA UDI | Class I | Active |
| Oxymixer Configuration | Configuration | FDA UDI | Class II | Active |
| Quality Connect HD | UI025 | FDA UDI | Class I | Active |
| Quality Connect HD | UI026 | FDA UDI | Class I | Active |
| QualityREG | DM-ISO-MS-NIST-CO2 | FDA UDI | Class I | Active |
| Quality Connect | UI020 | FDA UDI | Class I | Active |
| Oxymixer Low Flow SET | Low Flow SET | FDA UDI | Class II | Active |
| Oxymixer Low Flow 15LPM | Low Flow 15LPM | FDA UDI | Class II | Active |
| QualityREG | DM-AD-CO2-NIST-DIN-K | FDA UDI | Class I | Active |
| Quality Connect HD | UI024 | FDA UDI | Class I | Active |
| QualityREG | DM-DIN6-MS-NIST-CO2 | FDA UDI | Class I | Active |
| Quality Connect | UI021 | FDA UDI | Class I | Active |
| Quality Connect | RW-CO2-ZGV-NIST-5,0 | FDA UDI | Class I | Active |
| Quality Connect | UI022 | FDA UDI | Class I | Active |
| Oxymixer High Flow SET | High Flow SET | FDA UDI | Class II | Active |
| Quality Mix Blender, Oxymixer | K221494 | FDA 510(k) | Class II | Active |
| QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) | K241366 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- DEHAS Medical Systems GmbH Luebeck Schleswig-Holstein · DE FEI 3013156250