Medikro 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
- Not established by any record (our catalog import lists it as manufacturer; that is not evidence of the role)
- Role
- Role not established by any record
- Location
- Kuopio, 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. 4 official records from 3 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. Nothing here confirms manufacturing, 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] 3 public contracts on record, the latest awarded 2025-07-02. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2025-07-02. 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)
- 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)
- 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 2026-07-09. Finnish Patent and Registration Office (PRH)
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 2 medical devices: MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX (K120577, 2015-06-24), MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO (K133428, 2014-05-21). 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)
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)