Miris Ab

FDA Filings

This page includes the latest FDA filings for Miris Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3013887826
FEI Number3013887826
NameMIRIS AB
Owner & OperatorMiris AB
Contact AddressKungsgatan 115
Uppsala SE-C Uppsala lan [SE-03] 75318 SE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressKungsgatan 115
Uppsala Uppsala lan [SE-03], 75318 SE
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Miris AB
 Miris Calibration Control Kit™ 05-07-1012022-05-12
Miris AB
 Miris Cleaner™ 39-04-001 2020-06-23
Miris AB
 Miris Check™ 39-01-003 2020-06-23
Miris AB
 Miris Human Milk Analyzer™ 08-02-1072019-05-01
MIRIS AB
Miris Calibration Control Kit2019-04-26
MIRIS AB
Miris Human Milk Analyzer2019-02-20
Miris AB
Miris Human Milk Analyzer2018-12-21

Related Finance Registrations
NCAGE CodeAF05NMIRIS AB
NCAGE CodeSCMN6MIRIS AB
CAGE CodeAF05NMIRIS AB
CAGE CodeSCMN6MIRIS AB
S.A.M. RegistrationSCMN6 [632704677]MIRIS AB
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