BIOSERENITY MEDICAL DEVICES GROUP
FR-MF-000039391 · France · Paris
BIOSERENITY MEDICAL DEVICES GROUP is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 28 |
|---|
Most frequent device types declared: 5100-00021-UN.
Among these devices, 16 are declared active.
Devices declared under this manufacturer
- Bioserenity Link
- Neuronaute® BioAdapter
- Neuronaute® High-Capacity Battery module
- Neuronaute® IceAdapter
- Neuronaute® IceCap 2
- Neuronaute® Mobile App Android
- Neuronaute® Mobile App iOS
- Neuronaute® Plus - Low Noise Extender
- Neuronaute® Plus - Touchproof extender
- Neuronaute® VEEG Pack
- Neuronaute®IceCap Neonate (XS)
- Neuronaute®Plus- DB25 Extender
Showing 12 of 28 declared devices.
Catalogue references include 1001-01020-UN, 1001-05001-UN, 1001-15016-UN, 1001-15018-EU, 1001-15020-UN, 1001-15021-UN.
European nomenclature codes declared: N01010299, Z12101080, Z12101082, Z12101085, Z12101003, Z12040182.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BIOSERENITY MEDICAL DEVICES GROUP (FR) · FDA 3014027738 |
| Devices in EUDAMED | 28 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 28 |
|---|---|
| Found in the U.S. device database | 15 |
| Share | 53.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIOSERENITY MEDICAL DEVICES GROUP |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2023-08-24 |
Licence types: Device Family (1), System (1).
Licensed under: ICECAP PRODUCT LINE, NEURONAUTE PLUS SYSTEM.
North American profile: Both markets. BIOSERENITY MEDICAL DEVICES GROUP is registered in both the United States and Canada.