Ambu
Dispositivos médicos, suministros sanitarios y productos clínicos.
Ambu fabrica dispositivos médicos, suministros sanitarios y productos clínicos a partir de sus operaciones en Ballerup. La empresa abastece a compradores de hospitales, distribuidores clínicos, sistemas de salud o clientes de exportación en sus mercados primarios listados.
- Type
- brand seeking distribution
- Location
- Ballerup, Denmark
- Founded
- 1937
- Website
- ambu.com
- Categories
- Suministros médicos y sanitarios, Suministros industriales
- Markets
- Dinamarca, Estados Unidos, Alemania, Japón
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)