Planmed 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
- Helsinki, Finland
- Categories
- Suprimentos médicos e de saúde
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 10 official records from 8 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
- Active taxpayer registration (record type: tax-filing-active) [official record; status green] Registered as an active taxpayer. checked 2026-09-18. Finnish Tax Administration, public corporate tax data 2024 (Verohallinto)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-09-17. Ministero della Salute, banca dati e Repertorio dei dispositivi medici
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 14 medical devices: Planmed XFI (K250318, 2025-09-26), Planmed Clarity 2D, Planmed Clarify S (K211720, 2022-07-18), Planmed Verity (K213278, 2022-04-28) +11. 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)
- 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 2026-10-09. 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 2026-10-09. Finnish Patent and Registration Office, Trade Register (PRH/YTJ open data)
- On the safety regulator's register of authorised operators (record type: supervised-operator) [official record; status green] Indicates a regulator lets it do work that needs a permit, and keeps checking it. checked 2026-09-19. Tukes register of operators (Finnish Safety and Chemicals Agency)
- manufacturing-practice-certified (record type: manufacturing-practice-certified) [official record; status green] A regulator of health products inspected this site and certified how it manufactures the product class named, for example medical devices or cosmetics. It is about manufacturing practice at the site, not a medicines licence. checked 2026-10-03. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- Street address on file in the state register (record type: registered-address) [official record; status green] Registered address: Sorvaajankatu 7, 00880 Helsinki. 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] Indicates the company is not dissolved or winding down. checked 2026-07-09. Finnish Patent and Registration Office (PRH)
- Mentioned in independent media (record type: media-mention) [our own observation, not an official record; status green] The press has written about it. A fact, not an endorsement. checked 2026-07-15. Imaging Technology News
- Takes part in public tenders (record type: public-contract-awarded) [official record; status green] 1 public contracts on record, the latest awarded 2025-11-27. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2025-11-27. TED (Tenders Electronic Daily), EU public procurement award notices Aqui a adjudicação traz também uma verificação feita por outros: na UE e no EEE o comprador público tem de excluir concorrentes condenados por fraude, corrupção ou branqueamento, e aqueles com dívidas fiscais ou contributivas fixadas por decisão definitiva. Essa verificação valeu para esse concurso na data da adjudicação: não mostra a situação atual da empresa, e uma adjudicação não mostra que o contrato foi executado. Directive 2014/24/EU, Article 57 (exclusion grounds)
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)