| Primary Device ID | 03615220003785 |
| NIH Device Record Key | 61f71c26-b43a-4121-bb65-1cb40140abc4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioSerenity-Link |
| Version Model Number | 5100-00021-UN |
| Company DUNS | 281224773 |
| Company Name | BIOSERENITY MEDICAL DEVICES GROUP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03615220003785 [Primary] |
| OUG | Medical Device Data System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-12-28 |
| Device Publish Date | 2023-01-12 |
| 03615220003846 - Neuronaute Touchproof Adapter | 2025-04-25 The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one e |
| 03615220003952 - Neuronaute® IceCap Neonate (M) | 2025-04-25 The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurol |
| 03615220003969 - Neuronaute® IceCap Neonate (S) | 2025-04-25 The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurol |
| 03615220003976 - Neuronaute® IceCap Neonate (XS) | 2025-04-25 The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurol |
| 03615220003471 - Neuronaute - IceAdapter | 2025-04-18 Neuronaute - IceAdapter is a cable that enables to plug the Neuronaute IceCap electrodes with another DB25 cable and be connecte |
| 03615220003679 - Neuronaute Plus Touchproof Extender | 2024-05-30 |
| 03615220003983 - Neuronaute Plus- Holding Band | 2024-03-29 |
| 03615220003655 - Neuronaute Plus - DB25 Extender | 2024-02-28 |