Planmeca

What is established and what is not

No researcher review has been written for this company yet. 8 official records from 7 official sources are on file. 5 other entries are not official records: 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. Nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.

Facts on file, each with its evidence type

• Certificates named on their own site (record type: certificate-page-on-site; this record does not by itself establish manufacturing) [stated or published by the company, not an official record; status amber] Shows where the company itself claims the certificate, so you can open that page and judge it. checked 2026-10-14. Company's own certification page
• EAEU product declaration on record, company's role not established (record type: eaeu-product-declaration-party; this record does not by itself establish manufacturing) [official record; status green] An official EAEU register holds a declaration for specific goods that names this company; the record we hold does not say in which role (manufacturer, applicant or representative). It shows those products may be sold on the EAEU market, not a general quality mark. Paste the document number into the register search to see the record. checked 2026-08-16. EAEU unified register of certificates and declarations
• Registered with the U.S. FDA (active, renewed for the current year) (record type: fda-registered) [official record; status green] Registered with the US food and drug regulator, renewed for the current year. checked 2026-10-14. FDA
• No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. checked 2026-10-14. OpenSanctions
• No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. checked 2026-10-14. OpenSanctions
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 23 medical devices: Planmeca Viso (K230985, 2023-12-28), Planmeca Romexis (K200572, 2020-12-02), Planmeca Viso (K181576, 2018-09-13) +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)
• 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 2026-10-14. Domain registry record
• 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)
• Line of business as recorded in the state register: Manufacture of other medical and dental instruments and supplies (record type: registry-activity) [official record; status green] Line of business as recorded in the state register: Manufacture of other medical and dental instruments and supplies Matched to this company by name only; no second anchor confirms it is the same legal entity.. Shows what the state itself says the company does, which you can compare with what it promises you. checked 2026-10-14. Finnish Patent and Registration Office (PRH)
• Legally registered and still active (record type: registry-active-global) [official record; status green] Indicates the company is not dissolved or winding down. checked 2026-10-14. Finnish Patent and Registration Office (PRH)
• Takes part in public tenders (record type: public-contract-awarded) [official record; status green] 1 public contracts on record, the latest awarded 2026-05-19. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2026-05-19. TED (Tenders Electronic Daily), EU public procurement award notices 在这里，中标还附带了别人做过的审查：在欧盟和欧洲经济区，公共采购方必须排除因欺诈、腐败或洗钱被定罪的投标人，以及经终局裁决认定拖欠税款或社会保险费的投标人。 这项审查只针对那次招标、截至授标之日：它不说明公司今天的状况，中标也不说明合同已经履行。 Directive 2014/24/EU, Article 57 (exclusion grounds)
• Business email on the company's own domain (record type: corporate-mail-on-domain) [our own observation, not an official record; status green] Shows the domain runs its own email rather than a free mailbox. It describes the domain, not who owns it. checked 2026-10-14. Mail server of the company domain
• 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

Claimed certifications, not confirmed by us

• ISO 13485, Medical Devices Quality IAF CertSearch
• CE Marking EU NANDO (notified bodies)

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)

Check independently

Before a first order, ask for the ISO 13485, Medical Devices Quality certificate number, its holder and the products it covers.

• Sanctions and watchlists (OpenSanctions)