ELOS MEDTECH PINOL A/S

Listed in a source registry

US FDA device registration and listing (open.fda.gov)

What is established and what is not

No researcher review has been written for this company yet. 5 official records from 5 official sources are on file. 2 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. 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

• Listed in a source registry (record type: listed-in-registry) [official record; status amber] Listed in Erhvervsstyrelsen; entry number 13746184. Matched to this company by name only; no second anchor confirms it is the same legal entity.. Found in a named public register, not only on its own website. checked 2026-09-02. BRIS, EU business registers interconnection (e-justice.europa.eu)
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 7 medical devices: Elos Accurate® Denture Fixation System (K253774, 2026), Elos Accurate Hybrid Base (K251497, 2025), Elos Accurate® Hybrid Base™ (K242025, 2024) +4. 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)
• Site address listed in a government regulator's register (record type: facility-registered) [official record; status green] Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. checked 2026-08-07. US FDA device establishment registration (openFDA)
• 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)
• 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-09-02. 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-09-02. OpenSanctions
• 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 2026-09-02. FDA

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)

Goods family established: Artykuły i sprzęt dentystyczny (official record of a specific product). The exact product, operation and trade route needed to determine a product-specific requirement are not established here. Product-specific import rules not established for the catalog category Artykuły medyczne i związane z opieką zdrowotną: no record or company text names goods of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.

Check independently

• Sanctions and watchlists (OpenSanctions)