Ambu
Medical devices, healthcare supplies and clinical products.
Ambu manufactures medical devices, healthcare supplies and clinical products from its Ballerup operations. The company supplies hospital buyers, clinical distributors, healthcare systems or export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Ballerup, Denmark
- Founded
- 1937
- Website
- ambu.com
- Categories
- Medical & Healthcare Supplies, Industrial Supplies
- Markets
- Denmark, United States, Germany, Japan
Verified facts
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- domain-registered (green), checked 2026-08-02 Domain registry record
Claimed certifications
- 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)