Data / Medical devices / Sweden / Miris AB
Miris AB: FDA-registered device maker in Uppsala, Sweden, 2 510(k) clearances
Miris AB is registered with the FDA (registration 3013887826) in Uppsala, Sweden. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 29, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013887826
- Address
- Danmarksgatan 26, Uppsala, Sweden, 75323
- Owner or operator
- Miris AB (10059205)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 20, 2019
- Registered through
- 2026
- Brand names listed
- Miris Calibration Control Kit, Miris Human Milk Analyzer, Miris Human Milk Analyzer (HMA)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Breast Milk Macronutrients Test System | QEI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls Unassayed | OHQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2023 | K223085 | Miris Human Milk Analyzer (HMA) | QEI | Substantially Equivalent | Miris AB | accessdata.fda.gov |
| December 21, 2018 | DEN180007 | Miris Human Milk Analyzer | QEI | Unknown | Miris AB | accessdata.fda.gov |
Compare with other makers
Updated September 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.