Bittium Biosignals Oy
No description from the company. The catalog line you may see elsewhere is generated by us from the category and location, not a statement by the company.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Kuopio, Finland
- Categories
- Forniture medicali e sanitarie
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 8 official records from 6 official sources are on file. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- Takes part in public tenders (record type: public-contract-awarded) [official record; status green] 1 public contracts on record, the latest awarded 2025-11-14. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2025-11-14. TED (Tenders Electronic Daily), EU public procurement award notices Qui l'aggiudicazione porta con sé anche un controllo altrui: nell'UE e nello SEE la stazione appaltante deve escludere gli operatori condannati per frode, corruzione o riciclaggio e quelli con debiti fiscali o contributivi accertati con decisione definitiva. Quel controllo valeva per quella gara alla data dell'aggiudicazione: non mostra la situazione attuale dell'azienda, e un'aggiudicazione non mostra che il contratto sia stato eseguito. Directive 2014/24/EU, Article 57 (exclusion grounds)
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 1 medical devices: Faros Mobile (K182030, 2018-11-08). The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
- Street address on file in the state register (record type: registered-address) [official record; status green] Registered address: Pioneerinkatu 6, 70800 Kuopio. The address the company itself gave the register, so post and inspectors reach it there. checked 2026-08-14. Finnish Patent and Registration Office, Trade Register (PRH/YTJ open data)
- Legally registered and still active (record type: registry-active-global) [official record; status green] Shows the register lists the registration as active on the date we read it. It does not show how busy the business is. checked 2026-07-09. Finnish Patent and Registration Office (PRH)
- Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. checked 2026-10-16. Finnish Patent and Registration Office, Trade Register (PRH/YTJ open data)
- Line of business as recorded in the state register: Manufacture of irradiation, electromedical and electrotherapeutic equipment (record type: registry-activity) [official record; status green] Line of business as recorded in the state register: Manufacture of irradiation, electromedical and electrotherapeutic equipment. Shows what the state itself says the company does, which you can compare with what it promises you. checked 2026-10-16. Finnish Patent and Registration Office, Trade Register (PRH/YTJ open data)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-15. Ministero della Salute, banca dati e Repertorio dei dispositivi medici
- Active taxpayer registration (record type: tax-filing-active) [official record; status green] Registered as an active taxpayer. This is a tax registration status, not accounts: it shows no revenue or profit. checked 2026-10-16. Finnish Tax Administration, public corporate tax data 2024 (Verohallinto)
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)