The regulatory status of our products is maintained here. If something changes, it changes here first.
Syn-R1 research edition is a passive, reusable scalp electrode for the acquisition of electroencephalography (EEG) signals in research settings. It is supplied for research use only. It is not a certified medical device, has not been assessed for clinical safety or performance, and must not be used for the diagnosis, monitoring, treatment or prevention of any disease or condition. Use in human studies is subject to the ethical approval of the user's institution.
Syn-R1 clinical edition is the same design built in medical-grade materials as a single-patient, single-use device, intended for the acquisition of EEG signals in clinical settings once certified. It is in development and is not yet available for clinical use.
| Device type | Non-invasive, passive scalp electrode. No energy is delivered to the patient. |
|---|---|
| European Union | Class I under EU MDR 2017/745. CE marking in progress for the clinical edition. |
| United Kingdom | Class I under the UK Medical Devices Regulations. UKCA marking in progress alongside CE. |
| United States | Class II. FDA pathway to follow EU and UK certification. |
| Other markets | Assessed on demand once CE and UKCA marking are granted |
| Research edition | Research use only. Not a certified medical device. |
| Intellectual property | Patent-pending, application 2615593.7, covering EEG, fNIRS, tDCS and tACS |
| Legal manufacturer | Synaptive Ltd, company number 16195899, United Kingdom |
Declarations of conformity, certificate details and the Instructions for Use are published here as each marking is granted.
Every research edition electrode and shipment carries a research-use-only statement. Users are responsible for use in accordance with their institution's ethical approval and applicable law.
Performance described on this site refers to bench and research use. We make no clinical claims for either edition until the clinical edition is certified. If a page is unclear, tell us.
If a Syn-R1 electrode is involved in an incident, an unexpected effect on a participant, or a product defect, tell us immediately. Every report is logged and investigated, and where required we notify the relevant competent authority.
admin@synaptiveltd.co.uk. Include what happened, when, the electrode format and batch if known, the equipment in use, and whether anyone was affected. Keep the unit if you can, so we can examine it.
We confirm receipt and assign a reference, and may contact you for detail. Serious incidents are escalated immediately. You will be told the outcome.