MIRIS AB

FDA Device Registration & Listing · Uppsala, SE · Registration 3013887826

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013887826
FEI Number
3013887826
Entity Name
MIRIS AB
City/State/Country
Uppsala, SE
Establishment Address
Danmarksgatan 26, Uppsala 75323, SE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Miris AB (Owner Number: 10059205)
Owner / Operator Contact Address
Danmarksgatan 26, Uppsala, SE-C 75323, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN180007
PMA Number
N/A

All Registered Proprietary Names

Miris Human Milk Analyzer (HMA) Miris Calibration Control Kit Miris Human Milk Analyzer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QEI Breast Milk Macronutrients Test System Clinical Chemistry Class 2 862.1493 2023-10-13
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2019-04-26
QEI Breast Milk Macronutrients Test System Clinical Chemistry Class 2 862.1493 2019-02-20

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants Inc Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

Miris AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013887826. Last updated year: 2026. Please use registration number 3013887826 when referencing this establishment in official correspondence.
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