Duo-Max Blood Pressure & Glucose Monitor Hmf-100
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080636 FDA 510(k)
- FDA Product Code
- CGA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Duo-Max Blood Pressure and Glucose Monitor HMF-100 is a dual-function device classified as a Blood Pressure Measuring Device and Glucose Monitoring Device (Glucose Oxidase Method). It simultaneously measures blood pressure and capillary blood glucose levels, providing real-time diagnostic data for cardiovascular and metabolic health assessment.
This device is intended for single-use in clinical and home settings, requiring no sterilisation. It is non-reusable and designed for point-of-care use, with no MRI safety considerations specified. Supplied as a complete kit, it is authorised under FDA 510(k) clearance and MDR compliance, adhering to regulatory standards for Class II medical devices (FDA classification). No additional storage or handling restrictions are noted beyond standard medical device protocols.
Frequently asked questions
What clinical settings is the Duo-Max Blood Pressure & Glucose Monitor HMF-100 designed for, and how does its dual-functionality benefit users?
The Duo-Max HMF-100 is designed for both clinical and home settings, making it versatile for point-of-care use in hospitals, clinics, or patient self-monitoring. Its dual-functionality—simultaneously measuring blood pressure and capillary blood glucose levels—eliminates the need for separate devices, streamlining workflows for healthcare providers and improving convenience for patients by providing real-time diagnostic data for cardiovascular and metabolic health assessment in a single session.
Is the Duo-Max HMF-100 reusable, or is it intended for single-use? How does this impact its use in clinical environments?
The Duo-Max HMF-100 is intended for single-use only, with no sterilization required. This design reduces contamination risks in clinical settings, as each device is discarded after use. For healthcare providers, this means no reprocessing is needed, simplifying infection control protocols and ensuring consistent performance without wear-and-tear concerns.
How is the Duo-Max HMF-100 supplied, and are there any special storage or handling requirements beyond standard medical device protocols?
The Duo-Max HMF-100 is supplied as a complete kit, ready for immediate use without additional preparation. While no specialized storage restrictions are explicitly noted, it adheres to standard medical device protocols for handling, ensuring stability and usability. Since it’s single-use, storage should follow general guidelines for minimizing exposure to moisture, extreme temperatures, or physical damage.
Does the Duo-Max HMF-100 have any MRI safety considerations, and what does this mean for patients or facilities?
The Duo-Max HMF-100 does not specify MRI safety considerations, meaning it is not designed to be used in or near MRI environments. For patients, this implies the device should not be brought into an MRI scanner room. Facilities should ensure the device is stored away from MRI areas to prevent interference or mislabeling, as its materials or components may not be MRI-compatible.
What regulatory pathways does the Duo-Max HMF-100 follow, and how does this affect its availability or use in different markets?
The Duo-Max HMF-100 is authorized under FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for Class II medical devices in the U.S. and EU markets, respectively. This means it has undergone rigorous evaluation for safety and performance, ensuring its use is compliant with both FDA and EU medical device regulations. Clinicians and buyers can rely on its adherence to these pathways for clinical and commercial deployment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K080636 | Class II | Active |
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Manufacturer
- Manufacturer
- HuBDIC Co., Ltd.
Sources (2)
- FDA 510(k) K080636 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026