Miris AB

FDA Regulatory Profile

Miris AB appears in FDA public data with 0 recalls, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Feb 15, 2024 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Sep 29, 2023.

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Summary

Total Recalls
0
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 15, 2024Uppsala, SwedenDevicesNo Action Indicated (NAI)3013887826

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K223085Miris Human Milk Analyzer (HMA)Sep 29, 2023
DEN180007Miris Human Milk AnalyzerDec 21, 2018