Optomed Oyj
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
Optomed è un produttore leader di fotocamere fundus portatili a livello globale. Consentiamo lo screening oculistico a tutti, ovunque si trovino.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Oulu, Finland
- Website
- https://optomed.com
- 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. 7 official records from 6 official sources are on file. 1 other entry is not an official record: our own technical checks and searches, open directory listings, our inferences or the company's own statements. 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
- Website domain registered (record type: domain-registered) [our own observation, not an official record; status green] Shows how long this web address has been registered. That is the age of the domain, not of the company: a domain can change owners. checked 2026-08-23. Domain registry record
- 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)
- Active legal entity ID (LEI) (record type: lei-active) [official record; status green] A global identifier used in finance; an active one is renewed yearly. checked 2026-08-23. GLEIF global LEI register (golden copy)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-17. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- 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: Optomed Smartscope M5 with Optomed Smartscope FA (K201325, 2020-11-20). 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)
- 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 2026-10-16. Finnish Patent and Registration Office, Trade Register (PRH/YTJ open data)
- 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 2026-09-10. GLEIF Global LEI record
- Line of business as recorded in the state register: Retail sale of other medical and orthopaedic goods (record type: registry-activity) [official record; status green] Line of business as recorded in the state register: Retail sale of other medical and orthopaedic goods. 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)
Relationships
1 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.
Candidates, not confirmed
- optomed.com: Website of this business. Source record
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)