Miris Human Milk Analyzer
FDA 510(k)Class II (US FDA 510(k))
by Miris AB
Identifiers
- 510(k) Number
- DEN180007 FDA 510(k)
- FDA Product Code
- QEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1493 FDA 510(k)
- Regulation Number
- 862.1493 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Miris Human Milk Analyzer is a clinical chemistry device used to analyze breast milk for individual nutrition of preterm babies. It quantitatively measures the energy, fat, carbohydrate, and protein content in human milk in a single run.
The device is used with the Miris Ultrasonic Processor for sample preparation and is supplied in multiple countries. It is a Class II medical device with FDA 510K clearance and product code QEI. The analyzer is not specified as single-use or reusable, and no MRI safety information is provided.
Frequently asked questions
What is the Miris Human Milk Analyzer used for?
The Miris Human Milk Analyzer is a clinical chemistry device that quantitatively measures the energy, fat, carbohydrate, and protein content in human milk. It is specifically designed for analyzing breast milk to provide individualized nutrition for preterm babies.
How is the Miris Human Milk Analyzer supplied?
The device is supplied in multiple countries and is used in conjunction with the Miris Ultrasonic Processor for sample preparation. It is a Class II medical device with FDA 510K clearance and product code QEI.
Is the Miris Human Milk Analyzer single-use or reusable?
The device is not specified as single-use or reusable in the provided information. Users should refer to the manufacturer's instructions for specific guidance on usage and disposal protocols.
What regulatory approvals does the Miris Human Milk Analyzer have?
The Miris Human Milk Analyzer has FDA 510K clearance with product code QEI. It is classified as a Class II medical device and was reviewed by the Clinical Chemistry advisory committee.
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. Sources consulted: Miris, Miris HMA™ Human Milk Analyzer - mirissolutions.com, Miris HMA®
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN180007 | Class II | Active |
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Manufacturer
- Manufacturer
- Miris AB
Sources (1)
- FDA 510(k) DEN180007 24 fields · synced Sep 25, 2026