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
- 医療およびヘルスケア用品
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 ここでの落札は、他者による審査も伴います。EUおよびEEAでは、公共調達者は詐欺、汚職、資金洗浄で有罪となった入札者、および確定した決定で税や社会保険料の未納が認定された入札者を排除しなければなりません。 この審査はその入札の落札日時点のものです。会社の現在の状況を示すものではなく、落札は契約が履行されたことを示すものでもありません。 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)