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:
| Registration Number | 3014745300 | ||||||||
| FEI Number | 3014745300 | ||||||||
| Name | COALA LIFE AB | ||||||||
| Owner & Operator | Coala Life AB | ||||||||
| Contact Address | Riddargatan 18 Stockholm SE-AB Stockholms lan [SE-01] 11451 SE | ||||||||
| Official Correspondent |
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| US Agent |
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| Importing Logistics Registration |
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| Registration Status | 1 | ||||||||
| Initial Importer | N | ||||||||
| Registration Expiration | 2020-04-25 | ||||||||
| Registration Address | Riddargatan 18 Stockholm Stockholms lan [SE-01], 11451 SE | ||||||||
| Establishment Type | Manufacture Medical Device |
| Registration Number | 3015549547 |
| FEI Number | 3015549547 |
| Name | Coala Life Inc. |
| Owner & Operator | Coala Life AB |
| Contact Address | Riddargatan 18 Stockholm SE-AB Stockholms lan [SE-01] 11451 SE |
| Official Correspondent |
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| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 3333 Michelson Drive Suite 300 Irvine, CA 92612 US |
Device Company | Device | Date |
|---|---|---|
Coala Life AB | Coala Heart Monitor | 2022-04-14 |
| Coala-Life AB | Coala Heart Monitor US Rx N/A | 2019-07-19 |
COALA LIFE AB | Coala Heart Monitor | 2019-05-17 |
Coala Life AB | Coala Heart Monitor | 2019-02-08 |