This page includes the latest FDA filings for Curetis G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3013723824 |
| FEI Number | 3013723824 |
| Name | Curetis USA Inc. |
| Owner & Operator | Curetis GmbH |
| Contact Address | Max-Eyth-Strasse 42 Holzgerlingen DE-BW Baden-Wurttemberg 71088 DE |
| Official Correspondent |
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| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 10525 VISTA SORRENTO PKWY # 104 San Diego, CA 92121 US |
| Registration Number | 3014470579 |
| FEI Number | 3014470579 |
| Name | Curetis GmbH |
| Owner & Operator | Curetis GmbH |
| Contact Address | Max-Eyth-Strasse 42 Holzgerlingen DE-BW Baden-Wurttemberg 71088 DE |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | Robert-Bosch-Strasse 4 Bodelshausen Baden-Wurttemberg, 72411 DE |
| Establishment Type | Manufacture Medical Device |
| Registration Number | 3009850816 |
| FEI Number | 3009850816 |
| Name | Gail e. Radcliffe |
| Owner & Operator | Curetis GmbH |
| Contact Address | Max-Eyth-Strasse 42 Holzgerlingen DE-BW Baden-Wurttemberg 71088 DE |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 231 FAIRBANKS ST WEST BOYLSTON, MA 01583 US |
| Establishment Type | Develop Specifications But Do Not Manufacture At This Facility |
Device Company | Device | Date |
|---|---|---|
| Curetis GmbH | Acuitas 12001 | 2023-04-25 |
| Curetis GmbH | Acuitas 62006 | 2023-04-25 |
| Curetis GmbH | Acuitas 62005 | 2023-04-25 |
| Curetis GmbH | Acuitas 12002 | 2023-03-23 |
| Curetis GmbH | Unyvero 10091 | 2020-01-23 |
Gail e. Radcliffe [Curetis GmbH] | Unyvero LRT BAL Cartridge Kit | 2019-12-27 |
Curetis GmbH | Unyvero LRT BAL Cartridge Kit | 2019-12-27 |
Curetis GmbH | Unyvero LRT BAL Application | 2019-12-20 |
| Curetis GmbH | Unyvero 60003 | 2018-09-12 |
| Curetis GmbH | Unyvero 10020 | 2018-07-06 |
| Curetis GmbH | Unyvero 10049 | 2018-07-06 |
| Curetis GmbH | Unyvero 60002 | 2018-06-28 |
| Curetis GmbH | Unyvero 60001 | 2018-06-28 |
Gail e. Radcliffe [Curetis GmbH] | Unyvero M1 Master Mix Tube Kit | 2018-04-12 |
Gail e. Radcliffe [Curetis GmbH] | Unyvero LRT Cartridge Kit | 2018-04-12 |
Gail e. Radcliffe [Curetis GmbH] | Unyvero L4 Lysator | 2018-04-12 |
Gail e. Radcliffe [Curetis GmbH] | Unyvero C8 Cockpit | 2018-04-12 |
Gail e. Radcliffe [Curetis GmbH] | Unyvero A50 Analyzer | 2018-04-12 |
Curetis GmbH | Unyvero M1 Master Mix Tube Kit | 2018-04-12 |
Curetis GmbH | Unyvero LRT Cartridge Kit | 2018-04-12 |
Curetis GmbH | Unyvero L4 Lysator | 2018-04-12 |
Curetis GmbH | Unyvero C8 Cockpit | 2018-04-12 |
Curetis GmbH | Unyvero A50 Analyzer | 2018-04-12 |
Curetis GmbH | Curetis Unyvero LRT Application | 2018-04-03 |
| NCAGE Code | CM809 | CURETIS GMBH |
| CAGE Code | CM809 | CURETIS GMBH |
| S.A.M. Registration | CM809 [312621863] | CURETIS GMBH |