Ambu
Ballerup, Denmark
Danish medical device company focused on single-use devices, including single-use endoscopes and resuscitators.
Business types in Ballerup
Regulation in Denmark
Denmark is in the EU / EEA, so the EU framework applies.
Regulator: European Commission (DG SANTE) with national competent authorities of EU/EEA Member States
Two EU regulations govern medical devices and IVDs in the EU/EEA; devices need CE marking after the conformity assessment route set by their risk class.
From the sourced EU MDR / IVDR entry, checked 29 October 2026. General information, not legal advice. Requirements for Denmark · All medical certifications
Frequently asked questions
Should I check a Danish supplier’s device role before signing a supply agreement?
Yes, as in any EU country. Under the EU MDR, the manufacturer, authorized representative, importer and distributor have different legal duties, and one company can hold several roles. Ask a Danish supplier which role it holds for each product line. If it is a distributor, ask who the legal manufacturer is; if it imports from outside the EU, ask for its EUDAMED registration as importer.
Also ask how complaints and incidents reach the manufacturer and the Danish Medicines Agency. A short role statement in the supply agreement avoids gaps. Listings are on the Denmark country page.