Radiometer Medical ApS
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
Radiometer is een Deens bedrijf in medische apparatuur dat bloedgasanalysatoren, transcutane m…
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
- Copenhagen, Denmark
- Founded
- 1935 (from our catalogue record; not confirmed by the company or by a state register)
- Website
- radiometer.com
- Categories
- Medische en gezondheidszorgbenodigdheden
- Markets
- Verenigde Staten, Duitsland, Japan, Verenigd Koninkrijk, Frankrijk, Australië, China
What is established and what is not
No researcher review has been written for this company yet. 9 official records from 9 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
- 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 2026-08-02. Domain registry record
- First recorded on the web archive (record type: web-presence-since) [our own observation, not an official record; status green] The company website was already online in 1998. Shows a web archive saw a page at this address on that date. It does not show who ran the site then. checked 2026-08-04. Internet Archive (Wayback)
- 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
- 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 2026-09-07. GLEIF global LEI register (golden copy)
- Market access approved: European Union (record type: market-access-eu) [official record; status green] Shows the establishment is approved for the listed activities under the EU food-hygiene rules and appears in the EU list of approved establishments. It is not an import check and not an observation of current production. checked 2026-08-22. TRACES NT, European Commission register of approved establishments (DG SANTE)
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 21 medical devices: AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (K163462, 2017), ABL800 FLEX with AQURE connectivity (K142898, 2015), Hematocrit and Metabolite QUALICHECK (K150226, 2015) +18. 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)
- Annual accounts filed with the register (record type: annual-accounts-filed) [official record; status green] Indicates the company still meets its reporting duties. checked 2026-09-23. Erhvervsstyrelsen, offentliggjorte årsrapporter (virk.dk)
- 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)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-03. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- Takes part in public tenders (record type: public-contract-awarded) [official record; status green] 2 public contracts on record, the latest awarded 2025-05-02. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2025-05-02. TED (Tenders Electronic Daily), EU public procurement award notices Hier draagt de gunning ook een controle van een ander: in de EU en de EER moet een publieke inkoper inschrijvers uitsluiten die zijn veroordeeld voor fraude, corruptie of witwassen, en degenen bij wie een definitief besluit belasting of premieschulden heeft vastgesteld. Die controle gold voor die aanbesteding op de datum van gunning: ze toont niet de huidige situatie van het bedrijf, en een gunning toont niet dat het contract is uitgevoerd. Directive 2014/24/EU, Article 57 (exclusion grounds)
- 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
- ISO 9001, Quality Management 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.