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Sign in to claim this brandMequ A/S
US
Last updated May 24, 2026
What Mequ A/S makes
Mequ A/S manufactures conduction blood and fluid warmers designed to maintain the temperature of intravenous fluids and blood products during medical procedures. The portfolio includes modular systems such as starter kits, standalone warmers, power packs, chargers, and integrated stations for clinical use.
These devices are classified as Class II under FDA regulations and are listed via 510(k) and UDI pathways. The company is based in the United States.
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 Mequ A/S manufacture?
Mequ A/S specializes in conduction blood and fluid warmers. These devices are designed to maintain the temperature of intravenous fluids and blood products during medical procedures, ensuring optimal conditions for patient safety and treatment effectiveness. The company’s portfolio includes modular systems like standalone warmers, power packs, chargers, and integrated stations, all tailored for clinical use.
Where is Mequ A/S based?
Mequ A/S is based in the United States. The company’s location in the US aligns with its focus on regulatory compliance and market access for its conduction blood and fluid warmers, which are intended for use in healthcare settings within the country.
Which regulatory registries list Mequ A/S’s devices?
Mequ A/S’s conduction blood and fluid warmers are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These pathways are used to demonstrate compliance with FDA requirements for Class II devices, ensuring traceability and regulatory transparency for healthcare providers and authorities.
How are Mequ A/S’s devices classified under FDA regulations?
Mequ A/S’s conduction blood and fluid warmers fall under Class II classification according to FDA regulations. This classification is based on the devices’ intended use and risk level, requiring compliance with specific controls to ensure safety and effectiveness without needing the stringent premarket approval process reserved for higher-risk Class III devices.
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
- 305297593
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| °M Warmer System - Starter Kit | MWS005 | FDA UDI | Class II | Active |
| °M Warmer System - °M Warmer | MWS201 | FDA UDI | Class II | Active |
| °M Warmer System - Power Pack | MWS105 | FDA UDI | Class II | Active |
| °M Warmer System - Charger | MWS301 | FDA UDI | Class II | Active |
| °M Warmer System - Power Pack+ | MWS106 | FDA UDI | Class II | Active |
| °M Warmer System - Starter Kit+ | MWS006 | FDA UDI | Class II | Active |
| °M Warmer System | K232107 | FDA 510(k) | Class II | Active |
| °M Warmer System with °M Station | K260988 | FDA 510(k) | Class II | Active |
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