This page includes the latest FDA filings for Bioserenity. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3015147363 |
| FEI Number | 3015147363 |
| Name | BIOSERENITY INCORPORATED |
| Owner & Operator | BIOSERENITY |
| Contact Address | 47 BOULEVARD DE L HOPITAL INSTITUT DU CERVEAU ET DE LA MOELLE EPIN PARIS CEDEX 13 FR-J Ile-de-France 75646 FR |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1251 avenue of the Americas 3rd FL c/o Pramex International New York, NY 10020 US |
| Registration Number | 3014027738 |
| FEI Number | 3014027738 |
| Name | BIOSERENITY |
| Owner & Operator | BIOSERENITY |
| Contact Address | 47 BOULEVARD DE L HOPITAL INSTITUT DU CERVEAU ET DE LA MOELLE EPIN PARIS CEDEX 13 FR-J Ile-de-France 75646 FR |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 47 BOULEVARD DE L HOPITAL ICM-iPEPS - HOPITAL PITIE SALPETRIERE - CS 21414 PARIS CEDEX 13 Ile-de-France, 75646 FR |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| BIOSERENITY | Bioserenity Cloud | 2023-08-29 |
| BIOSERENITY | Accusom 1017-15004-US | 2023-05-04 |
| BIOSERENITY | Accusom 1017-15014-US | 2023-05-04 |
| BIOSERENITY | Accusom 1017-10001-US | 2023-05-04 |
| BIOSERENITY | Neuronaute Touchproof Adapter 1001-15024-US | 2023-05-02 |
| BIOSERENITY | Neuronaute Application Mobile iOS 5100-00012 | 2021-02-23 |
| BIOSERENITY | Bioserenity Cloud 1012-21002-US | 2021-02-23 |
| BIOSERENITY | Neuronaute 1.2 - Head module 1001-10004-US | 2021-02-23 |
| BIOSERENITY | Neuronaute IceCap 1001-01010-US | 2021-02-23 |
BIOSERENITY | Cardioskin Cloud | 2018-10-11 |
BIOSERENITY | Cardioskin App | 2018-10-11 |
BIOSERENITY | Cardioskin | 2018-08-14 |
BIOSERENITY | Neuronaute | 2018-03-15 |
BIOSERENITY | Neuronaute | 2018-03-15 |
BIOSERENITY | NEURONAUTE | 2017-12-26 |