Miris AB

Address:Danmarksgatan 26,Uppsala,SE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Breast Milk Macronutrients Test System (QEI) (3) Multi-Analyte Controls Unassayed (OHQ) (1)

Premarket Exempt

No Yes

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Miris Check™ - 07350107530027 Catalog Number : 39-01-003

Device Description : Zero-setting solution for Miris Human Milk Analyzer™. Concentrate, 10 mL. Dilute Zero-setting solution for Miris Human Milk Analyzer™. Concentrate, 10 mL. Dilute the content with 90 mL distilled or deionized water and mix. Warm to 35-40° C before use.

Device Class : 2

Duns Number: 632704677

Premarket Exempt : No

Product Code : QEI

Prescription Use : No

Device Count : 1

Miris Cleaner™ - 07350107530034 Catalog Number : 39-04-001

Device Description : Cleaning agent for Miris Human Milk Analyzer™.Concentrate, 50 mL. Dilute the con Cleaning agent for Miris Human Milk Analyzer™.Concentrate, 50 mL. Dilute the content with 950 mL distilled or deionized water and mix. Warm to 35-40°C before use.

Device Class : 2

Duns Number: 632704677

Premarket Exempt : No

Product Code : QEI

Prescription Use : No

Device Count : 1

Miris Calibration Control Kit™ - 07350107530041 Catalog Number : 05-07-101

Device Description : Quality control material for the Miris Human Milk Analyzer™. Miris Calibration C Quality control material for the Miris Human Milk Analyzer™. Miris Calibration Control Kit™ includes standardised solutions in two concentrations, Miris Calibration Control 1 and Miris Calibration Control 2. One package contains 20 vials, 10 vials of each solution. One vial of each solution constitute one kit. 8 ml liquid volume per vial. Warm the solutions to 35-40°C and homogenize the vial content, according to the method indicated in the instructions for use, before use.

Device Class : 1

Duns Number: 632704677

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 10

Miris Human Milk Analyzer™ - 17350107530079 Catalog Number : 08-02-107

Device Description : The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, protein, and carbohydrate in human milk. The Miris HMA also provides calculated values for total solids and energy. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants. This device is intended for use in healthcare by trained healthcare personnel at clinical laboratories.

Device Class : 2

Duns Number: 632704677

Premarket Exempt : No

Product Code : QEI

Prescription Use : Yes

Device Count : 1

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