IceCap product line
Bioserenity Medical Devices Group
BIOSERENITY MEDICAL DEVICES GROUP
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014027738 | 3014027738 | BIOSERENITY MEDICAL DEVICES GROUP | 1 | N | 2026-01-01 | 6/8 rue Jean Antoine de Baif PARIS CEDEX 13 Ile-de-France FR 75013 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 324011 | 1491525407 | K243788 | IceCap product line | GXY | 2025-03-13 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GXY | 1 | 2025-03-13 |
PMN#
GUDID#
Neuronaute IceCap 2 Small - The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
2026-03-17
Neuronaute IceCap 2 - The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
2025-11-28
Neuronaute Touchproof Adapter - The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one edge and 21 touchproof on the other edge. It will allow to connect the Neuronaute IceCap to a compatible EEG recorder through the touchproof connection.
2025-04-17
Neuronaute - IceAdapter - Neuronaute - IceAdapter is a cable that enables to plug the Neuronaute IceCap electrodes with another DB25 cable and be connected to a compatible EEG monitoring system.
2023-01-12
Neuronaute IceCap 2 - The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
2023-01-25
Neuronaute - IceAdapter - Neuronaute - IceAdapter is a cable that enables to plug the Neuronaute IceCap electrodes with another DB25 cable and be connected to a compatible EEG monitoring system.
2025-04-18
Neuronaute IceCap 2 Small - The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
2023-01-25
Neuronaute Touchproof Adapter - The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one edge and 21 touchproof on the other edge. It will allow to connect the Neuronaute IceCap to a compatible EEG recorder through the touchproof connection.
2023-04-24
Neuronaute® IceCap Neonate (M) - The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
2025-04-17
Neuronaute® IceCap Neonate (S) - The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
2025-04-17
Neuronaute® IceCap Neonate (XS) - The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
2025-04-17
Neuronaute Plus Touchproof Extender - 1001-15023-UN
2024-05-22
Neuronaute Plus- Holding Band - 1001-05001-UN
2024-03-21
Neuronaute Plus - DB25 Extender - 1001-15021-UN
2024-02-20
Neuronaute Plus- IceCap Extender - 1001-15022-UN
2024-02-20
Neuronaute Plus - Core Module - 1001-10006-US
2024-02-20
Neuronaute Mobile Application Android - 5100-00024
2024-02-20
Neuronaute 1.2 - High capacity battery module - The Neuronaute Battery High Capacity module is a removable, rechargeable electronic device. The battery is recharged using a charging station. It connects to the Neuronaute BioAdapter using 3 snap buttons located on its rear.
2023-01-12
Neuronaute 1.2 - BioAdapter - It enables the connection of the Neuronaute Head Module and the Neuronaute High Capacity battery module to the Neuronaute IceCap or a specific set of reusable cup electrodes manufactured with Ag/AgCl discs connected to a lead wire. The wire is insulated and terminates with a touch proof connector (DIN 42802)
2023-01-12
Neuronaute 1.2 - Battery charger - Neuronaute 1.2 - Battery charger is a charging station for the Neuronaute Battery High Capacity module.
2023-01-12
BioSerenity-Link - BioSerenity-Link is a mobile application capable of sharing phone connectivity, recording video and uploading it to the BioSerenity Cloud
2023-01-12
Bioserenity Cloud - Bioserenity CLOUD is a web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi connection. The cloud platform enables long-term storage and display of the recorded signals.
2021-02-15
Neuronaute 1.2 - Head module - Neuronaute Head Module is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations in order to assist in the diagnosis of neurological disorders by a physician.
2021-02-15
Neuronaute Application Mobile iOS - 5100-00012
2021-02-15
Cardioskin Textile S20 - 1005-00009-US
2019-01-22
Cardioskin Textile S22 - 1005-00001-US
2019-01-22
Cardioskin Textile S24 - 1005-00006-US
2019-01-22
Cardioskin Textile S30 - 1005-00007-US
2019-01-22
Cardioskin Textile S32 - 1005-00002-US
2019-01-22
Cardioskin textile S34 - 1005-00003-US
2019-01-22
Cardioskin Textile S41 - 1005-00004-US
2019-01-22
Cardioskin Textile S42 - 1005-00010-US
2019-01-22
Cardioskin Textile S43 - 1005-00005-US
2019-01-22
Cardioskin Textile S44 - 1005-00008-US
2019-01-22
Cardioskin Recorder - 1005-10001-US
2019-01-22
Cardioskin Dock - 1005-15001-US
2019-01-22
Cardioskin Battery - 1005-15002-US
2019-01-22
Cardioskin Charger - 1005-15003-US
2019-01-22
Neuronaute head S40 - 1001-01004-US
2019-01-22
Neuronaute head S42 - 1001-01005-US
2019-01-22