This page includes the latest FDA filings for Auris Health Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3008975424 |
| FEI Number | 3008975424 |
| Name | AURIS HEALTH, INC. |
| Owner & Operator | Auris Health, Inc. |
| Contact Address | 150 Shoreline Drive Redwood City CA 94065 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2383 Bering Dr San Jose, CA 95131 US |
| Establishment Type | Manufacture Medical Device |
| Registration Number | 3014447948 |
| FEI Number | 3014447948 |
| Name | AURIS HEALTH, INC. |
| Owner & Operator | Auris Health, Inc. |
| Contact Address | 150 Shoreline Drive Redwood City CA 94065 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 150 Shoreline Drive Redwood City, CA 94065 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| AURIS HEALTH, INC. | Bronchoscope Sheath Valve MBR-000020 | 2024-05-13 |
| AURIS HEALTH, INC. | Monarch Bronchoscope MRB-000211-A | 2024-05-13 |
| AURIS HEALTH, INC. | Bronchoscope Fluidics Tubing MBR-000218 | 2024-05-13 |
| AURIS HEALTH, INC. | Monarch Bronchscope 2.0/Monarch Platform (P2) | 2024-05-13 |
| AURIS HEALTH, INC. | Monarch™ Laptop P17/P73 Linux USB Image v2.2.5 | 2024-02-26 |
| AURIS HEALTH, INC. | Monarch™ Laptop P70 Linux USB Image v2.2.5 | 2024-02-26 |
| AURIS HEALTH, INC. | Monarch™ Software Cart v2.2.5 | 2024-02-26 |
| AURIS HEALTH, INC. | Monarch™ Software Tower v2.2.5 | 2024-02-26 |
| AURIS HEALTH, INC. | Monarch Endoscopy Platform (P1) System, Refurbished | 2023-06-19 |
| AURIS HEALTH, INC. | Monarch™ Laptop P17/P73 Linux USB Image v2.2.4 | 2023-02-13 |
| AURIS HEALTH, INC. | Monarch™ Laptop P70 Linux USB Image v2.2.4 | 2023-02-13 |
| AURIS HEALTH, INC. | Monarch™ Software Cart v2.2.4 | 2023-02-13 |
| AURIS HEALTH, INC. | Monarch™ Software Tower v2.2.4 | 2023-02-13 |
Auris Health Inc | Monarch Platform, Urology | 2022-04-29 |
| AURIS HEALTH, INC. | Bronchoscope Fluidics Tubing MBR-000218 | 2021-11-23 |
| AURIS HEALTH, INC. | Monarch Advanced Imaging Accessory Kit MON-000709 | 2021-07-23 |
Auris Health, Inc. | Monarch Platform | 2021-07-09 |
| AURIS HEALTH, INC. | Monarch Bronchoscope MBR-000211-B | 2021-05-21 |
| AURIS HEALTH, INC. | Monarch Bronchoscope MRB-000211-A | 2021-05-13 |
| AURIS HEALTH, INC. | Monarch Bronchoscope MBR-000211-A | 2021-03-25 |
| AURIS HEALTH, INC. | Monarch Endoscopy Platform (P1) Tower Upgrade | 2020-07-21 |
| AURIS HEALTH, INC. | Monarch Bronchscope 2.0/Monarch Platform (P2) | 2020-07-10 |
| AURIS HEALTH, INC. | Monarch Endoscopy Platform (P1) Tower Upgrade | 2020-07-10 |
Auris Health, Inc. | Monarch Platform | 2020-04-15 |
| AURIS HEALTH, INC. | Monarch Software Laptop v2.2.1 | 2020-03-13 |
| AURIS HEALTH, INC. | Monarch Software Cart v2.2.1 | 2020-03-13 |
| AURIS HEALTH, INC. | Monarch Software Tower v2.2.1 | 2020-03-13 |
| AURIS HEALTH, INC. | Monarch Software Laptop v2.1.6 | 2020-03-13 |
| AURIS HEALTH, INC. | Monarch Software Cart v2.1.6 | 2020-03-13 |
| AURIS HEALTH, INC. | Monarch Software Tower v2.1.6 | 2020-03-13 |
| AURIS HEALTH, INC. | Navigation Patient Patches MBR-000016 | 2019-10-23 |
| AURIS HEALTH, INC. | Monarch™ Software Laptop v2.1.5 | 2019-09-18 |
| AURIS HEALTH, INC. | Monarch™ Software Cart v2.1.5 | 2019-09-18 |
| AURIS HEALTH, INC. | Monarch™ Software Tower v2.1.5 | 2019-09-18 |
| AURIS HEALTH, INC. | Monarch™ Software Laptop v2.1.4 | 2019-05-20 |
| AURIS HEALTH, INC. | Monarch™ Software Cart v2.1.4 | 2019-05-20 |
| AURIS HEALTH, INC. | Monarch™ Software Tower v2.1.4 | 2019-05-20 |
| AURIS HEALTH, INC. | Monarch™ Platform (Refurbished) MON000005R | 2019-05-20 |
| AURIS HEALTH, INC. | Bronchoscope Fluidics Tubing MBR-000018 | 2019-04-23 |
| AURIS HEALTH, INC. | Monarch™ Software Laptop v2.1.3 | 2018-11-15 |
| AURIS HEALTH, INC. | Monarch™ Software Cart v2.1.3 | 2018-11-15 |
| AURIS HEALTH, INC. | Monarch™ Software Tower v2.1.3 | 2018-11-15 |
| AURIS HEALTH, INC. | Monarch™ Software Laptop v2.1.2 | 2018-07-09 |
| AURIS HEALTH, INC. | Monarch™ Software Cart v2.1.2 | 2018-07-09 |
| AURIS HEALTH, INC. | Monarch™ Software Tower v2.1.2 | 2018-07-09 |
| AURIS HEALTH, INC. | Monarch™ Platform MON000005 | 2018-07-09 |
| AURIS HEALTH, INC. | Bronchoscope Sheath Valve MBR-000020 | 2018-07-09 |
| AURIS HEALTH, INC. | Bronchoscope Valve MBR-000019 | 2018-07-09 |
| AURIS HEALTH, INC. | Bronchoscope Patient Introducer Kit MBR-000017 | 2018-07-09 |
| AURIS HEALTH, INC. | Cytology Brush MBR-000015 | 2018-07-09 |
| AURIS HEALTH, INC. | Biopsy Forceps - Smooth Cup MBR-000014 | 2018-07-09 |
| AURIS HEALTH, INC. | Aspirating Biopsy Needle MBR-000012 | 2018-07-09 |
| AURIS HEALTH, INC. | Monarch™ Bronchoscope System MBR-000011 | 2018-07-09 |
AURIS HEALTH, INC. | Monarch Platform | 2018-04-09 |
AURIS HEALTH, INC. | Monarch Platform | 2018-04-09 |
AURIS HEALTH, INC. | Monarch Platform | 2018-04-09 |
AURIS HEALTH, INC. | Monarch Platform | 2018-04-09 |
| NCAGE Code | 89FE7 | AURIS HEALTH, INC. |
| CAGE Code | 89FE7 | AURIS HEALTH, INC. |
| S.A.M. Registration | 89FE7 [15823456] | AURIS HEALTH, INC. |
| DUNS | 015823456 | Auris Health, Inc. |
| SEC | 0001464814 | AURIS HEALTH, INC. of DELAWARE |