Coala Life Ab

FDA Filings

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

Coala Life Ab holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3014745300
FEI Number3014745300
NameCOALA LIFE AB
Owner & OperatorCoala Life AB
Contact AddressRiddargatan 18
Stockholm SE-AB Stockholms lan [SE-01] 11451 SE
Official Correspondent
  • Johanna Tulkki
  • 46-8-270077-x
US Agent
Importing Logistics Registration
ImporterCoala Life AB
AddressRiddargatan 18
Stockholm, 11451 SWEDEN
Phone46 8 270077
SubdivisionSE-AB
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressRiddargatan 18
Stockholm Stockholms lan [SE-01], 11451 SE
Establishment TypeManufacture Medical Device



Registration Number3015549547
FEI Number3015549547
NameCoala Life Inc.
Owner & OperatorCoala Life AB
Contact AddressRiddargatan 18
Stockholm SE-AB Stockholms lan [SE-01] 11451 SE
Official Correspondent
  • Johanna Tulkki
  • 46-8-270077-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address3333 Michelson Drive Suite 300
Irvine, CA 92612 US



FDA Filings

Device
Company
DeviceDate
Coala Life AB
Coala Heart Monitor2022-04-14
Coala-Life AB
Coala Heart Monitor US Rx N/A2019-07-19
COALA LIFE AB
Coala Heart Monitor2019-05-17
Coala Life AB
Coala Heart Monitor2019-02-08

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