Bittium Biosignals Ltd

Bittium Biosignals Ltd produces biosignal measurement devices such as the Mini UL, Bittium Physior, BrainStatus, Faros14D and the Respiro HSAT system, plus accessories like ECG adapters and RIP belt patches. These products are intended for cardiology and neurology applications, including home sleep‑apnea testing, because the company’s description emphasizes biosignal measuring in those areas.

The company is based in Finland, as indicated by the country code FI. Its devices are listed in the European Union’s Eudamed database, which is the official EU registry for medical devices, because the data explicitly states the listing location.

All listed products fall into either Class I or Class IIa categories. This classification follows the EU MDR rules for low‑ to medium‑risk devices, and the source data directly assigns those two classes to the company’s portfolio.

Yes, the company provides accessories such as the Respiro ECG Adapter, OmegaSnap 1‑CH Adapter, Respiro 1 RIP Belt Patch, OmegaSnap 1‑CH ECG Electrode, and a Charger Dock. These items support the primary biosignal platforms by enabling ECG connections, respiratory monitoring, and power management, which is necessary for the intended cardiology and neurology measurements.

The information does not state that the company itself is approved; rather, individual devices receive authorization. The data only mentions device classification and listing in Eudamed, so any claim of company‑wide approval would be unsupported and therefore omitted.